-
Sr. Quality Engineer
- Medtronic (Brooklyn Park, MN)
-
We anticipate the application window for this opening will close on - 18 Mar 2026
Position Description:
Sr. Quality Engineer for Medtronic, Inc located in Brooklyn Park, MN. Responsible for developing and maintaining quality standards for processing materials, collaborating with engineering and manufacturing teams, and implementing process improvements. The position also includes conducting quality assurance tests, performing statistical analysis, and ensuring corrective measures meet reliability standards. Responsible for technical assessments and compliance activities to ensure that reliability and safety is proactively designed into our products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. Perform Risk Mgmt. Deliverables to include Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis. Support Design and Process Control deliverables to include Product Performance Specifications, Design Verification, Design Validation, approve product drawings/prints, Process Characterization and Process Validation. Provide support for Variable and Attribute Test Method Development and Validation. Provide support for Complaint and Product Failure Investigations, post market root cause analysis, Corrective and Preventive Actions (CAPA) and Non- Conforming Material Requests (NCMR). Navigate government and quality regulations to include FDA 21 CFR part 820 and part 211 requirements and ISO 13485, ISO 9001 and ISO 14971. Utilize statistical tools and software to include Design of Experiments (DOE), ANOVA, Confidence and Tolerance Limits, Gage R&R, Capability analysis and Six Sigma Methodology in auditing and ensuring quality outcomes. Provide specialized knowledge in the manufacturing process of Coating of medical devices for perfusion systems including Biocompatible coatings with and without Active Pharmaceutical ingredients (API), manufacturing of combination products. Coordinate Control Environment Area (CEA) Validations, Control Environment Area Excursion Analysis and investigation and utilize computer and software packages to include MS Office Suite, MS Project, MS Access, Minitab and SAP. #LI-DNI.
**Basic Qualifications:** Bachelors’ Degree or foreign equivalent in Nanotechnology, Mechanical, Industrial, Chemical or Biomedical Engineering or related engineering field. Requires four (4) years’ experience in Quality Engineer for Medical devices. Must possess at least four (4) years’ experience in each of the following: Risk Mgmt. Deliverables to include Process FMEA and Product Hazard Analysis; Variable and Attribute Test Method Development and Validation; Design and Process Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, Process Characterization and Process Validation; Complaint and Product Failure Investigations, post market root cause analysis, CAPA, and Non-Conforming Material Reports; FDA 21 CFR part 820 and part 211ISO 13485, ISO 9001, and ISO 14971; DOE, ANOVA, Confidence and Tolerance Limits, Gage R&R, Capability analysis, and Six Sigma Methodology; Coating of medical devices for perfusion systems, Biocompatible coatings with and without Active Pharmaceutical ingredients (API), manufacturing of combination products; Control Environment Area (CEA) Validations, Control Environment Area Excursion Analysis and investigation.
The position reports to Medtronic, Inc., 7611 Northland Drive, Brooklyn Park, MN 55428.
**Salary:** $109,000 to $145,200 per year.
THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com
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 [email protected]
To request removal of your personal information from our systems please email [email protected]
-