We anticipate the application window for this opening will close on - 2 Jul 2026

**Position Description:**

Sr. Design Quality Engineer for Covidien, LP (a Medtronic company), Perform Quality engineering activities in support of new product development. Work cross-functionally to review requirements and identify and assess product risks, and mitigation strategies, as well as review protocols and reports to support product validation. Support Systems NPD Quality team in performing engineering analysis to ensure design quality, analyzing system, and sub-system risk, technical writing, resolving high-profile quality issues, and product improvements for robust design. Utilize Medical device design controls, product risk files, and lean sigma methodologies, including Define, Measure, Analyze, Improve, and Control (DMAIC), Design for Reliability (DfR) and Design for Manufacturing (DfM). Utilize DOE (Design of Experiments), SPC (Statistical Process Control), Variable Gage R & R, ANOVA (analysis of Variance), t-test, regression analysis, Process Capability, Confidence & Tolerance interval analysis and process control. Evaluate products and process risks using d/p Failure Mode, Effects, and Criticality Analysis (FMECA), utilizing ISO 14971. Navigate New Product Development Life Cycle. Leverage QMS (Quality Mgmt. System) processes including CTQ (Critical to Quality) and knowledge of FDA 21 CFR part 820 ISO 13485:2003 medical device materials, related processes, and GDP (Good Documentation Practices). Utilize design capability, value stream and process mapping, and 5S. Troubleshoot production and other issues utilizing problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why’s and Ishikawa (Fishbone). Leverage Corrective and Preventive actions (CAPA) with use of RCA (Root Cause Analysis) to solve problems, document conditions and create solutions to avoid future problems. Leverage statistical software including (electronic quality mgmt. system) eQMS and Minitab. Collaborate on predictive complaint analysis and conduct post-market product performance reviews to identify and mitigate potential design and quality issues. Relocation assistance is not available for this position. Position works a hybrid model and will be onsite in Boston, MA–4 days per week. #LI-DNI

**Basic Qualifications:**

Masters’ Degree in Mechanical, Biomedical or Bio-Engineering or related engineering field and two (2) years of experience as a product development engineer, quality engineer or related occupation in quality engineering or product development engineering or Bachelor’s degree in Mechanical, Biomedical or Bio-Engineering or related engineering field and five (5) years of experience as a product development engineer, quality engineer or related occupation in quality engineering or product development engineering. Must possess two (2) years’ experience in each of the following: Medical device design controls, product risk files, DMAIC, DfR , DfM, and Lean Six Sigma; DOE, SPC, Variable Gage R & R, ANOVA (analysis of Variance), t-test, regression analysis, Process Capability, Confidence & Tolerance interval analysis and process control; Product and Process risk utilizing d/p FMECA and ISO 14971; New Product Development Life Cycle; QMS process, identify CTQ, FDA 21 CFR Part 820, ISO 13485 and GDP; A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why’s and Ishikawa (Fishbone); CAPA and RCA; eQMS and Minitab; and Predictive Complaint Analysis.

**Salary:** $136,600 to $145,200 per year

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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