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Medtronic Quality Engineering Manager in Grand Rapids, Michigan

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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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 (https://www.e-verify.gov/employees) .

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 AskHR@medtronic.com

To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com

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