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We anticipate the application window for this opening will close on - 12 Aug 2025

Position Description:

Senior Quality Engineer for Covidien, LP, (a Medtronic company) located in Irvine, CA. Responsible for ensuring the quality and compliance of the manufacturing processes for a variety of vascular devices such as embolic coils, stents, catheters, balloons, aspiration devices, coatings, and guide wires. Leverage Good Manufacturing Practices (GMP) standards and navigate the complexity of government and medical device industry regulations including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and ISO 9001 standards to ensure products are consistently produced per the quality standards. Coordinate risk mgmt. activities in manufacturing utilizing PFMECA to identify and mitigate risks in manufacturing processes. Responsible for risk assessments to ensure thorough identification and evaluation of manufacturing risks. Coordinate Process Verification and Validation activities by conducting Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ) to verify and validate manufacturing equipment and processes. Implement Test Method Validation (TMV) to ensure the reliability of manufacturing test methods. Leverage critical analysis skills and Quality tools including 5 Whys, 6M, Ishikawa Diagram, and Pareto Charts for root cause analysis of the manufacturing processes. Utilize Lean Six Sigma principles to streamline manufacturing processes and enhance efficiency. Responsible Corrective and Preventive Actions (CAPA) and Non-Conforming Material Report (NCMR) of manufacturing processes by coordinating activities focused on addressing manufacturing non-conformances, determining root causes, and implementing corrective and preventive actions. Utilize statistical analysis skillset in the manufacturing domain leveraging statistical analysis tools for process capability and measurement system analysis, be able to utilize software including Minitab, to support manufacturing decisions. Apply Geometric Dimensioning and Tolerancing (GD&T) in the context of manufacturing to ensure parts are produced within specified tolerances. Responsible for generating and managing manufacturing documentation, including specifications, procedures, and sampling methods. Responsible for providing engineering coverage across various shifts including (1st and 2nd shifts), and providing continuous quality engineering support to the manufacturing operations. #LI-DNI

Basic Qualifications:

Master’s degree in Biomedical, Mechanical, Industrial Engineering or related engineering field and two (2) years of experience as a Quality Engineer or related quality engineering occupation, or Bachelor’s degree in Biomedical, Mechanical, Industrial Engineering or related engineering field and five (5) years of experience as a Quality Engineer or related quality engineering occupation. Must possess a minimum of two (2) years of experience with each of the following: FDA 21 CFR Part 820, ISO 13485, ISO 14971 & ISO 9001; Good Manufacturing Practices (GMP); Risk activities using FMECA, including DFMECA and PFMECA; IQ/OQ/PQ and Test Method Validation (TMV); Root cause investigations, 5 Whys, 6M, Ishikawa Diagram and Pareto Charts; Lean 6 Sigma; CAPA & NCMR; Minitab; and GD&T. Must be able to work/cover across both 1st and 2nd shifts.

**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) .

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