We anticipate the application window for this opening will close on - 12 Aug 2025 **Position Description:** Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Irvine, CA. Provide quality engineering support for the successful development of Neurovascular products. Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Work with vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and guide wires to ensure quality products. Utilize Statistical analysis tools including DOE (Design of Experiments), SPC (Statistical Process Control), ANOVA (Analysis of Variance), t-test, Process Capability, Confidence & Tolerance interval analysis with proficiency in Minitab. Utilize process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line. Coordinate Product and Process risk utilizing Process Failure Mode Effects and Criticality Analysis (PFMECA) and Design Failure Mode Effects and Criticality Analysis (DFMECA). Navigate government and industry standards to include FDA 21CFR part 820, ISO13485, ISO14971, Good Manufacturing Practices (GMP)and Good Documentation Practices (GDP). Provide Process Verification & Validation for product quality, including development and execution of protocols Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) and TMV (Test Method Validations). Coordinate root cause analysis using various quality tools (5 Whys, 6M and Ishikawa (Fishbone) Diagram) for failed product or processes. Participate in CAPA (Corrective and Preventive Actions) and implementation of corrective and preventive actions as necessary. Identify Critical to Quality (CTQ) product features, procedures for Inspecting testing and evaluating the precision, accuracy of products, production equipment and sampling methods as well as interpreting engineering drawing and GD&T (Geometric Dimensioning and Tolerancing). Relocation assistance not provided. #LI-DNI *Position works a hybrid model and will be onsite in Irvine, CA location – 4/5 days per week. May support 2nd Shift operations 3:00 PM to 12:00 AM. **Basic Qualifications:** Master’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or related field and two (2) years of experience as a quality engineer , manufacturing engineer, or in related occupation in quality or manufacturing engineering. Or, Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or related field and five (5) years of experience as a quality engineer , manufacturing engineer, or in related occupation in quality or manufacturing engineering. Must possess at least two (2) years’ experience with each of the following: DOE, SPC, ANOVA (Analysis of Variance), t-test, Process Capability, Confidence & Tolerance interval analysis; Product and Process risk utilizing DFMECA and PFMECA; FDA 21CFR 820, ISO13485, ISO14971 and GDP; Six sigma and lean principles; Process Verification & Validation to include IQ, OQ, PQ and TMV; Root cause analysis using 5 Whys, 6M and Ishikawa (Fishbone) Diagram; CAPA investigation and corrective action implementation; Identifying CTQ product features and sampling methods; Interpreting engineering drawing and GD&T. Position works a hybrid model and will be onsite in Irvine, CA location – 4/5 days per week. May support 2nd Shift operations 3:30 PM to 12:00 AM. Relocation assistance not provided. **Salary:** $130,600 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