Job Listings

Job Description

Welcome to the Future of Precision Oncology – Join Us in Wilmington, DE!

We’re thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware—a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. This is more than a job - it’s a chance to be part of the next wave of cancer care. Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute to life-changing therapies for patients around the world. Together, we’ll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact.

Join us in Wilmington and help shape the future of cancer treatment—one molecule at a time.

In this position the Technical Operations Associate Director will play a pivotal role in ensuring oversight of various aspects of manufacturing, change management and technology transfer of programs to the site. In partnership with site manufacturing team will provide comprehensive manufacturing and technical leadership to the DP organization supporting the continued build, commissioning and qualification. This position will continue within the role from design through operation of the facility.

Responsibilities

• Lead and engage with the engineering design firms in detailed design on all aspects of drug product manufacturing.
• Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary.
• Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT).
• Develop project appropriate guidance documents as necessary.
• Execute automation sprints as necessary in the drug product area.
• Support equipment qualification deliverables including equipment Commissioning & Qualification, IOQ, etc.
• Creation, review and revision of technical documents including manufacturing batch records, SOPs and technical memos.
• Provide Manufacturing and Technical expertise to the manufacturing team and leadership of the Technical Operations team, including areas such as formulation, filling, isolators, lyophilization and aseptic processing.
• Oversee the Engineering Batches, Process Performance Qualifications and commercial manufacturing including authoring relevant filing sections.
• Provide technical leadership for new product introductions (Tech Transfer).
• Support technical deliverables within Drug Product to support the successful product launch.
• Provide manufacturing and technical support for RFT implementation and execution.
• Communicate complex technical issues to stakeholders, external customers, agencies.

Qualifications

Required

• Bachelor’s degree in engineering, science or related discipline.
• Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility.
• Demonstrated ability to lead and operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Previous experience of manufacturing and technical support of shakedown batches, engineering batches, developmental batches and PPQ runs.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA.
• Ability to adapt to changing priorities as project demands change.
• Demonstrated skills in planning, communication (oral and written) and technical writing.

Preferred

• Start-up experience in a large-scale commercial drug product facility highly desirable with hands-on experience with antibody drug conjugates highly preferred.
• Expertise in drug product filling and lyophilization operations will be advantageous.
• Previous experience with CQV activities will be advantageous.

Required Skills:

Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), API Manufacturing, Change Control Systems, Change Management, Change Request Management, Chemical Process Development, Cross-Cultural Awareness, Cross-Functional Teamwork, Detailed Design, Equipment Qualification, GMP Compliance, Hazard Analysis, Manufacturing, Manufacturing Process Validation, Operational Acceptance Testing (OAT), People Leadership, Pharmaceutical Manufacturing, Process Characterization, Process Hazard Analysis (PHA), Process Optimization, Production Supervision, Regulatory Inspections, Regulatory Requirements, Results-Oriented {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/5/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Description

Our company is currently seeking an exceptional chemist for a group leader position within the Process Chemistry Department located at our Rahway, NJ site. A successful candidate will be joining a group of innovative laboratory scientists with broad deliverables ranging from the design of manufacturing routes for drug candidates to executing and coordinating deliveries of active pharmaceutical ingredient to support our company's pipeline and products. We are looking for a team player with strong leadership skills and ability and passion for mentoring and working along others in a laboratory setting. The candidate will work closely within multidisciplinary teams comprised of synthetic organic chemists, engineers, and external research partners

(both academic and industrial). A Ph.D. in chemistry or related discipline with a demonstrated ability for taking initiative and innovative problem solving is critical. A successful candidate is expected to apply cutting edge methodologies into synthetic routes to accelerate deliveries of active pharmaceutical ingredient to support pre-clinical and clinical studies. An established excellent reputation for scientific excellence supported by publications and external presentations is expected. Candidates must possess strong written and oral communication skills and the ability to drive results as a team leader.

Education Minimum Requirement

Ph.D. in Organic Chemistry or related discipline

Required Experience and Skills

• Minimum 7 years of experience with a proven track record of successful research in process chemistry
• Must have a strong track record of delivering results via innovation and fearless problem solving.
• Broad expertise in organic synthesis and experience in pharmaceutical process chemistry and adjacencies
• Demonstrated ability for taking initiative, creativity and innovation in problem solving
• Productivity and efficiency working in the laboratory
• Strong written and oral communication skills
• Excellent collaboration skills
• Established scientific reputation supported by publications and external presentations

Required Skills:

Academic Presentations, Accountability, Bioconjugation, Computational Chemistry, Creativity, Data Analysis, Deep Learning, High-Throughput Experimentation (HTE), Machine Learning (ML), Organic Synthesis, Professional Networking, Project Leadership, Research Proposal Development, Scientific Leadership, Scientific Literature Search, Strategic Thinking, Structure Based Drug Design, Synthetic Chemistry

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$173,200.00 - $272,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/28/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Senior Specialist, Engineering – GES Tech Center

Level – P3

Global Engineering Solutions (GES) is responsible for the design, construction, and delivery of advanced manufacturing facilities and laboratories worldwide. We provide premier engineering solutions in the pharmaceutical industry through technical innovation and project management to deliver important life-saving medicines and vaccines to patients. With our extensive range of facilities and environments, our Engineers have opportunities to impact Large and Small Molecule areas within our company's Manufacturing Division and Animal Health division lines of business, including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. Our Engineers provide solutions for internal and external manufacturing needs in support of operational efficiencies, continuous improvement, and innovations.

Our Animal Health Division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s largest economic development project to date. The Senior Specialist operates under the guidance of the GES Process Lead and is part of a high performing team accountable for implementation of this major project within our Company's growing portfolio of Animal Health work. The individual collaborates with other Integrated Project Team (IPT) members (e.g., Project Management, Technology, Maintenance, Automation, Plant Operations and Safety), Engineering Firms and Vendors to progress deliverables. The Senior Specialist would be responsible for leading the planning, design, and implementation of engineering solutions on a suite team. Core work includes equip/scope generation, process & facility design, equipment selection, vendor interaction, factory acceptance testing, technology transfer, construction support, equipment qualification, facility start-up and process demonstrations.

Preferred candidates will possess experience with engineering design, equipment operation, startup, and troubleshooting, and C&Q activities. They should demonstrate a proven aptitude for leading project design endeavors and offering creative solutions that align with business objectives. Additionally, the role may involve supervising junior engineers and collaboration with resources from an engineering firm.  Previous managerial experience in a similar position is desirable.

The Senior Specialist primary responsibility entails:

• Exhibiting strong technical/engineering leadership, interpersonal, collaboration and communication skills for both decision making and guiding team members.
• Leading a cross functional suite team of 5-10 members through the stage gates of a project and setting them up for success with knowledge transfer.
• Ensuring deliverables conform to our standards and practices; and are technically sound.
• Providing technical guidance during project implementation, assures viability of technology to meet design intent.
• Collaborating with other technical functions to ensure successful technology transfers of new and in-line products.
• Flexibility with travel up to 50%.

Job Description in Primary Posting Language

• This position will function as the technical/engineering process engineer with prior experience supporting Biologics, Vaccine and/or Sterile Projects.

Education Minimum Requirement:

• B.S. degree in Engineering (Chemical or Mechanical) or Science is required.  An advanced degree in Engineering, Science, or Business is preferred.

Required Experience and Skills:

• Minimum five (5) years of experience in Pharmaceutical/Biotech industry such as Process-Equipment Engineering Design,  Capital Project implementation, Technical Operations, or Operations/EMU.
• 3+ years experience leading cross functional teams in the startup and C&Q execution of capital projects.
• Experience with an equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification.
• Understanding of unit operations specific to vaccine/biologic manufacturing, including hygienic design and aseptic requirements for Buffer Prep, Formulation, and CIP/SIP and experience with primary and secondary packaging operations.
• Experience with capital projects that followed a stage gate capital management process.
• Excellent collaboration and engagement as a team player with dependable interpersonal and communication skills.
• Analytical and problem-solving skills.
• Multitasking/time management skills which deliver on time and quality work.
• Core knowledge should include specification of unit operations, P&ID reviews, Hazard Analysis, equipment operation, commissioning & qualification execution.
• Work independently and meet timelines in a fast-paced team-based environment.
• Strong self-motivation; proactive, high-energy, "can do" work ethic; ability to handle potentially stressful situations with a positive attitude.

Required Skills:

Adaptability, Capital Projects, Change Control Processes, Collaborative Communications, Construction, Customer-Oriented, Engineering Standards, Equipment Commissioning, Equipment Specifications, Global Engineering, Good Manufacturing Practices (GMP), Knowledge Transfer, Maintenance Engineering, Manufacturing Process Validation, Multitasking, Process Optimization, Project Implementations, Project Management, Self Motivation, Strategic Thinking, Teamwork, Technical Support, Technical Transfer, Working Independently

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/2/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

We anticipate the application window for this opening will close on - 20 May 2026 Position

Description

Responsible for the design, development, user validation and implementation of a complex PLM (including PDM Capabilities) across the enterprise and its integration with other systems like SAP. Coordinate the Product DNA initiative across the Medtronic enterprise, aimed at simplifying the creation, management, and utilization of product data. Establish a foundational, connected digital thread of product information by streamlining systems across the organization and implementing best-in-class practices and procedures. Utilize DMAIC (Define, Measure, Analyze, Improve, and Control) & DRM (Design, Reliability, and Manufacturability) methodology and Six Sigma to suggest design, development or manufacturing process improvement. Coordinate requirement flow-down process and requirement traceability utilizing requirement tools to include Cognition Cockpit and ability to develop the templates for flow-down. Responsible for leading and facilitating Agile development and deployment processes by managing cross-functional collaboration, prioritizing backlogs, ensuring quality delivery, and fostering continuous improvement to achieve project goals efficiently. Responsible for driving systems engineering excellence through continuous improvement, innovative problem-solving, and leading change initiatives to enhance organizational performance and efficiency. Conduct root-cause analysis into product and process failures and recommend corrective actions to prevent recurrence. Responsible for implementing Model-Based Systems Engineering (MBSE) and SysML to develop, analyze, and optimize system designs, ensuring traceability, collaboration, and alignment with engineering objectives. Responsible for managing and optimizing interconnected tool ecosystems to ensure seamless integration, enhance workflows, and drive efficiency across cross-functional teams. Responsible for analyzing and optimizing system architectures and alternatives using Mode-Frontier to perform trade-off studies, ensure alignment with objectives, and provide data-driven recommendations. Relocation assistance is not available for this position. #LI-DNI.

Basic Qualifications

Master's degree in mechanical engineering, electrical engineering, computer science or similar degree with an emphasis on Systems engineering. Requires Four (4) years of experience in Systems Engineering and Model Based Systems Engineering Theory and Implementation. Must possess at least four (4) years’ experience in each of the following: DMAIC & DRM methodology and Six Sigma; Flow-down process and requirement traceability; Agile methodologies, and AZDO for managing development and deployment; Implement systems engineering practices with a drive for continuous improvement; Investigation and root cause determination of Product & Process failures; Model Based Systems Engineering and SysML tools including EA, Magic Draw, Windchill Modeler; Multiple Tool Ecosystems, Inter-connected Tool Eco Systems, interface design and analysis; Analyze System Architectures and alternatives using Mode-Frontier; Demonstrated Participation and Presentation in INCOSE (International Council of Systems Engineering). Salary: $154,000 to $192,000 per year. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]

We anticipate the application window for this opening will close on - 28 May 2026 Position

Description

Design, develop, test, debug and implement operating systems components, software tools and utilities. Determine systems software design requirements. Ensure that system improvements are successfully implemented and monitored to increase efficiency. Generate systems software engineering policies, standards and procedures. Responsible for Software development in compliance with ISO 13485 and IEC 62304 standards including creation of design documentation. Coordinate risk strategies for medical devices in compliance with ISO 14971, including use of Failure Mode and Effects Analysis (FMEA) per IEC 60812. Utilize programing languages including C# and C++. Leverage MATLAB, Python, JavaScript, SQLite, MySQL, and WiX. Utilize Microsoft Application Lifecycle Mgmt. (ALM) services including Azure DevOps and Team Foundation Server. Responsible for the application of Artificial Intelligence and Machine Learning (AI/ML) to medical devices. Develop software for powered surgical equipment, intraoperative nerve monitors, or surgical navigation/medical imaging devices including MRI, CT, and X-Ray. Relocation assistance is not available for this position. *Position is required to be onsite at the Jacksonville, FL location 4 days per week. #LI-DNI.

Basic Qualifications

Bachelor’s degree in Software Engineering, Computer Science, Computational Science, Electronic Engineering or related engineering field and two (2) years’ experience as a software engineer or related occupation. Must possess at least two (2) years’ experience with each of the following: ISO 13485 and IEC 62304 including creation of design documentation; Risk mgmt. of medical devices, ISO 14971 and IEC 60812; C# and C++; MATLAB, Python, JavaScript, SQLite, MySQL, and WiX; ALM services including Azure DevOps and Team Foundation Server; Application of AI/ML to medical devices; and Developing software for powered surgical equipment, intraoperative nerve monitors, or surgical navigation/medical imaging devices for MRI, CT and X-Ray. Salary: $112,000 to $147,600 per year The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]

We anticipate the application window for this opening will close on - 18 Jun 2026 Position

Description

Responsible for designing and implementing software and web-based applications for Cardiac Rhythm and Heart Failure (CRHF) and Medical Device Software Products. Responsible for gathering, documenting, testing, and maintaining web and mobile application solutions. Design and execute functional and verification testing by developing test plans, automated test frameworks, and documenting bugs and test results as part of Product lifecycle mgmt. for CRHF products. Leverage Software Development Life Cycle (SDLC) models including Waterfall and Agile (SCRUM) and Software Testing Life Cycle (STLC) practices. Develop tests for custom medical device applications and navigate the complexities of the medical device industry by adhering to FDA Class I, II, and III medical device standards, IEC62304, and 21 CFR Part 820 and 21 CFR Part 806 regulations during Software development for Cardiac devices. Develop and maintain product applications incorporating C#, .Net, Python, SQL (Structured Query Language), and JavaScript. Responsible for integrating data with third party medical devices and connectivity vendors using HL7 2.x protocol. Utilize test and defect tracking tools including Microsoft TFS (Team Foundation Server), Visual Studio, and Azure DevOps. Perform front-end and back-end testing across platforms, including Windows, Android, Linux, and iOS, and utilize MS Server technologies including MS SQL and XML. Perform development and maintenance of Simple Object Access Protocol (SOAP) and Representational State Transfer (REST) web services and ensure connectivity between devices using Bluetooth, TCP/IP sockets, Serial communication, and Wi-Fi network protocols. Position will be onsite at the Mounds View, MN location at least 4 days per week. Relocation assistance is not available for this position. #LI-DNI.

Basic Qualifications

Masters’ Degree in Engineering Management, Software Engineering, Computer Engineering, Computer Science or related engineering or technical field and two (2) years of experience as a software engineer or software test engineer in the medical device industry. Must possess at least two (2) years’ experience with each of the following: SDLC using Waterfall and Agile (SCRUM) and STLC practices; FDA Class I, II, and III medical device standards, IEC62304, 21 CFR Part 820, and 21 CFR Part 806 ; C#, .NET Framework, Python, JavaScript, and SQL; HL7 2.x protocol; Back-end testing across platforms, including Windows, Android, Linux, and iOS, and MS Server technologies including MS SQL and XML; Microsoft TFS, Visual Studio, and Azure DevOps; Bluetooth, TCP/IP sockets, Serial communication, and Wi-Fi network protocols. Salary: $107,000 to $151,200 per year The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]

We anticipate the application window for this opening will close on - 25 Jun 2026 Position

Description

Lead the quality engineering team, ensuring that products and processes meet regulatory standards and Medtronic’s quality expectations. Oversee quality initiatives, support compliance, and drive continuous improvement across engineering and manufacturing operations. Manage and mentor a team of quality engineers, providing guidance, training, and performance feedback. Oversee the development, implementation, and maintenance of quality systems and processes in accordance regulatory requirements including Good Manufacturing Practices (GMP) standards, 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, EU Medical Device Regulation (MDR), and State of the Art (SOTA). Lead investigation and resolution of product quality issues and complaints, non-conformances, and CAPA (Corrective and Preventive Actions). Lead collaboration with engineering and manufacturing functions to investigate and resolve quality or compliance issues discovered during operations. Responsible for products in the form of finished medical devices within the Cardiac Surgery Business Unit by supporting manufacturing operations, evaluating compliance of materials and processes with specifications, and customer requirements in compliance. Lead Quality Engineering team for medical device components, ensuring that all finished good, and processes meet specifications. Ensure robust risk management and validation strategies are applied to products and processes, leveraging knowledge in Preliminary Hazard Analysis (PHA), and Process Failure Modes and Effects Analysis (PFMEA). Coach the use of Process Improvement tools, including Define, Measure, Analyze, Improve, and Control (DMAIC), Root Cause Analysis (RCA), 5 Whys, Fishbone, and cause mapping. Coach and lead Design of Experiments (DOE) methods for process development and statistical analysis tools for process capability (Cpk/Ppk), ANOVA, Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, and Test Method Validation (TMV). Oversee V&V (verification and validation) protocols, including Installation Qualification, Operational Qualification, Performance Qualification (IQ, OQ, and PQ). Utilize analytical tools including Minitab and Power BI for statistical analysis and data-driven decision-making. Manage product lifecycle mgmt. efforts, including overseeing quality systems and authoring technical documentation. Mentor and coach candidates pursuing First Time Quality (FTQ) Level 1 certification and provide strategic guidance for Level 1 and Level 2 Coach certification. Contribute to enterprise-wide FTQ initiatives and support multiple application areas to drive quality excellence. Relocation assistance not available for this position. #LI-DNI.

Basic Qualifications

Requires a Bachelor’s degree or foreign equivalent in Biomedical, Mechanical, Industrial Engineering or related engineering field and five (5) years of experience as a Quality Engineer or related occupation in medical device industry; or Master’s degree or foreign equivalent in Biomedical, Mechanical, Industrial Engineering or related engineering field and three (3) years of experience as a Quality Engineer or related occupation in medical device industry. Must possess at least three (3) years’ experience with each of the following: GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR, and SOTA; Risk Assessments, PHA, and PFMEA; Non-Conformances and CAPA; DMAIC, RCA, 5 Whys, Fishbone, and cause mapping; DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV; V&V protocols and IQ/OQ/PQ; Minitab and Power BI; Product lifecycle mgmt., including quality systems and authoring technical documentation; FTQ principles; and Cardiac surgery devices. Salary: $150,000 to $211,200 per year The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]

We anticipate the application window for this opening will close on - 25 Jun 2026 Position

Description

Sr. Software Engineer for Medtronic, Inc. in Mounds View, MN. Responsible for the design, development, and testing of software for medical devices per industry standards including ISO 13485, IEC 60601-1, IEC 62304 and IEC 82304. Plan projects, coordinate scope, and estimate work in collaboration with product owners, technology architects, and other software engineers. Create and participate in technical reviews of requirements, specifications, designs, code and other engineering artifacts, ensuring timely delivery to meet program commitments. Program within Java and C# and associated technologies including .Net framework. Utilize object-oriented programming (OOP), object-oriented analysis and design (OOAD), and software design patterns including Model View Controller (MVC) and Model View View Model (MVVM). Develop and test web-based User Interfaces using HTML, JavaScript, knockoutJS, AngularJS, and jQuery. Utilize software versioning and revision control systems to commit software utilizing Git, SVN, or TFS. Develop and test custom medical device applications using domain specific language. Relocation assistance is not available for this position. #LI-DNI.

Basic Qualifications

Master’s degree in Computer Engineering, Computer Science, Electrical Engineering, or related technical or engineering field and two (2) years’ experience as software engineer or related occupation in medical device industry. Must possess at least two (2) years’ experience with each of the following: Java, C#, and.Net framework; OOP, OOAD, and MVC and MVVM design patterns; Developing and testing web-based User Interfaces using HTML, JavaScript, knockoutJS, AngularJS, and jQuery; Software versioning and revision control systems utilizing Git and TFS; Creating software design and test and validation documents; Developing and testing custom medical device applications using domain specific language; and ISO 13485, IEC 60601-1, IEC 62304 and IEC 82304. Salary: $122,400 to $183,600 per year The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]

We anticipate the application window for this opening will close on - 25 Jun 2026 Position

Description

PD Program Manager for Medtronic, Inc. Lead released product management (RPM)/sustainment programs. Provide Technical and Engineering insights on energy-based products to assess impact of changes on overall function and performance of devices. Evaluate design and process impacts for changes incorporated as a part of remediation effort addressing field complaints and supplier component changes. Coordinate Voice of Customer (VOC) activities and formative and summative studies. Ensure compliance by navigating and adhering to government and industry regulations including FDA QSR 21 CFR 820, ISO 13485 (Medical Device), ISO 10993 (Biocompatibility), IEC 62366 (Usability Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software Development Life Cycle). Responsible for executing projects and ensuring effective collaboration with team members across different time zones and cultural environments. Utilize Monte Carlo simulations to assess and quantify risks and uncertainties across all phases of the project lifecycle, including design, development, testing, regulatory approval, and production. Conduct changes within the SAP environment, including SAP S/4HANA, SAP ECC and HP ALM to drive system enhancements, troubleshoot issues and ensure alignment with business processes. Define, execute, and document validation protocols Installation Qualification, Operational Qualification, Performance Qualification. (IQ/OQ/PQ). Lead the design and development of precision components for Injection Molding, Extrusion, and CNC Machining while conducting tolerance stack-up analysis to ensure dimensional accuracy and reliable performance in complex assemblies. Leverage CAD tools including PTC Creo, Minitab, SolidWorks, and AutoCAD within the design team, promoting best practices for 3D modeling, technical drawings, and design validation. Implement Design of Experiments (DOE), oversee the CAPA process and Non-Conforming Material Report (NCMRs). Responsible for strategic development, design, regulatory compliance, and clinical validation of Cerebrospinal Fluid (CSF) and cranial products, ensuring alignment with market needs, safety standards, and company objectives while collaborating with cross-functional teams to drive innovation and product success. Leverage knowledge from being a certified six sigma black belt by American Society of Quality (ASQ) or equivalent certifying agency. 10% international or domestic to suppliers and users. This is an individual contributor position with no direct reports. Relocation assistance not provided. #LI-DNI.

Basic Qualifications

Bachelor’s degree in Mechanical Engineering, Industrial Engineering or Biomedical Engineering or related engineering degree and five (5) years of experience as a manufacturing engineer or related engineering occupation; OR Master’s degree in Mechanical Engineering, Industrial Engineering or Biomedical Engineering or related engineering degree and two (2) years of experience as manufacturing engineer or related engineering occupation. Requires a minimum of 2 years of experience in each of the following: FDA QSR 21 CFR 820, ISO 13485 (Risk Mgmt.), ISO 10993 (Biocompatibility), IEC 62366 (Usability Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software Development Life Cycle); Collaborating with international team members; MS projects using Monte Carlo simulation; SAP S/4HANA, SAP ECC and HP ALM; IQ, OQ and PQ; Design for Injection Molding, extrusion, CNC machining and Tolerance stack up analysis; PTC Creo, Minitab, Solidworks and Auto CAD; DOE, CAPA and NCMR; and Working with Cerebrospinal Fluid (CSF) products. The following certification is required: Certified six sigma black belt by American Society of Quality (ASQ) or equivalent certifying agency. Travel requirement: 10% international or domestic to suppliers and users. Salary: $163,000 to $204,000 per year The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]

We anticipate the application window for this opening will close on - 30 Jun 2026 Position

Description

Principal Reliability Engineer for Medtronic, Inc located in Billerica, MA. Responsible for providing quality engineering support to ensure the successful development of Medtronic medical products. Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Update risk mgmt. documents to reflect updated or changed controls and mitigations, compliance evidence for standards, and risk estimates in response to post-market surveillance. Utilize Mechanical Geometric Dimensioning and Tolerancing (GD&T) and Root Cause Analysis (RCA). Navigate the complexities of government and industry regulations to include FDA 21 CFR Part 820, Current Good Manufacturing Practices (cGMP), ISO 14791, ISO 13485, ISO 9001, ISO 10012, and ISO 17025. Support various regulatory audits for Quality system process documents and records. Coordinate various Corrective & Preventive Actions (CAPA) programs as well as Lean Six Sigma, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP). Utilize risk analysis including Failure Mode Effect Analysis (FMEA), verification and validation (V&V), methodical problem solving, product design, and manufacturing engineering. Leverage Design of Experiments (DOE) and Statistical Analysis. Execute and utilize development protocols to include Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validations (TMV). Responsible for Capital equipment and single-use device design quality and design controls. #LI-DNI. The position will be onsite at the Billerica, MA location 4 days per week. Up to 25% domestic and international travel to various Medtronic project sites in Minneapolis, Minnesota; Boston, MA; Montreal, Canada; and Galway, Ireland. Reason: Project planning, support, and training

Basic Qualifications

Master’s degree in Mechanical or Biomedical Engineering or related engineering field and five (5) years of experience as a quality or manufacturing engineer or related engineering field. Experience must include a min. of five (5) years of each of the following: Mechanical GD&T and RCA; FDA 21 CFR Part 820, ISO 14971, ISO 13485, ISO 9001, ISO 10012, and ISO 17025; Supporting regulatory audits for Quality system process documents and records; Lean Six Sigma, GMP, GDP, and CAPA; Risk analysis, FMEA, V&V, methodical problem solving, product design, manufacturing engineering; DOE and statistical analysis; IQ/OQ/PQ, and TMV; Capital equipment and single-use device design quality and design controls. Up to 25% domestic and international travel to various Medtronic project sites in Minneapolis, Minnesota; Boston, MA; Montreal, Canada; and Galway, Ireland. Reason: Project planning, support, and training. The position will be onsite at the Billerica, MA location 4 days per week. Salary: $149,500 to $187,200 per year The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans Use this link to hyperlink We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]