We anticipate the application window for this opening will close on - 14 Oct 2025 **Position Description:** Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Fridley, MN. Responsible for New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Ensure the development and maintenance of high-quality, reliable, and safe medical devices that meet or exceed regulatory standards and customer expectations. Coordinate complaint investigations for Medtronic’s returned implantable devices. Accept and handle returned implantable devices, cleaning and sterilization process. Coordinate test results, clinical data, DHR (Device History Records) and product performance data. Perform Complaint analysis, complaint trending, predictive for newly developed products.. Responsible for Risk Mgmt. and Quality Controlled documents by updating relevant procedures and risk documents including (PHA, DFMEA and PFMEA) in compliance with the requirements of ISO 14971, ISO 13485, ISO 9001 and FDA QSR Part 820 and implementing best practices including (GDP) Good Documentation Practices. Perform Root Cause Analysis on identified non conformances by implementing methodological problem solving including DMAIC Process, Ishikawa Diagrams, Pareto Analysis, 5 Why Analysis. Implement process improvements by implementing Lean Six Sigma Techniques to include (COS) Cell Operating System, 5S, Gemba, Poka Yoke and Heijunka. Perform (TMV) Test Method Validations, Process Validations including Installation Qualification, Operational Qualification, Performance Qualification. (IQ,OQ,PQ) using effective Analysis including (MSA) Measurement System Analysis, Gage R&R Study, DOE (Design of Experiments) and application of statistical tools including Capability Analysis (CPK and PPK), SPC (Statistical Process Control), Control Charts, and ANOVA. Responsible for investigating identified non-conformances through formal investigation process including (CAPA) Corrective and Preventive Action. Responsible for combination(pharmaceutical and medical devices) products (FDA 21 CFR Part 4). Leverage knowledge from being a (ASQ) American Society of Quality Certified Quality Engineer (CQE). **Basic Qualifications:** Masters’ Degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering or related engineering field and two (2) years of experience as a manufacturing or quality engineer or related occupation in manufacturing or quality engineering. Must possess at least two (2) years’ experience with each of the following: Handling of returned implantable devices, cleaning and sterilization process; Review and analysis of test results, clinical data, DHR & product performance data; ISO 14971, ISO 13485, ISO 9001, FDA QSR Part 820 & GDP; RCA, DMAIC Process, Ishikawa Diagrams, Pareto Analysis and 5 Why Analysis; Lean Six Sigma Techniques, (COS) Cell Operating System, 5S, Gemba, Poka Yoke and Heijunka; SPC, Control Charts, IQ, OQ, and PQ; MSA, Gage R&R Study, DOE, Capability analysis (CPK, PPK), SPC, Control Charts, & ANOVA; CAPA; and Combination [pharmaceutical and medical device] Products, (FDA 21 CFR Part 4). The following Certification is required: ASQ CQE. Position works a hybrid model and will be onsite in Fridley, MN 3/4 days per week. **Salary:** $110,400 to $145,200 per year \#LI-DNI 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