Design Quality Engineer II - Hardware (Surgical Robotics)
About The Position
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position is onsite 4 days per week in North Haven, Connecticut. Our Medtronic Surgical team is working to bring the benefits of minimally invasive surgery (MIS) to more people and places through a portfolio of robotic and digital solutions. Together, we are working to broaden options and expand access globally for hospitals, surgeons, and patients. As a Design Quality Engineer II, you will play a critical role supporting the design quality, risk management, and U.S. launch of innovative surgical robotics systems, capital equipment, and instrumentation, including the Hugo™ platform. This design-focused quality role works at the intersection of R&D, manufacturing, supplier quality, and regulatory, supporting medical device designs from early development through manufacturing transfer and post-launch support. You will translate design and risk requirements into effective manufacturing controls, ensuring quality is built into the product from the outset, with a specific focus on hardware systems, electrical safety, and capital equipment performance in the field, while operating with a high degree of autonomy and cross-functional influence.
Requirements
- Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or a related hardware-focused technical discipline, plus: 2+ years of related work experience OR a Master’s degree with 0–2 years of related work experience
Nice To Haves
- Experience working with capital equipment or complex electromechanical medical devices
- Familiarity with IEC 60601 or other electrical safety standards
- Experience with hardware systems, PCBAs, or electromechanical components
- 2–5 years of experience in Electrical Engineering, Quality Engineering, Design Quality, Manufacturing Quality, or related roles
- Background in a regulated industry (medical devices strongly preferred; robotics, capital equipment, or aerospace highly relevant)
- Hands-on experience with design risk management, including DFMEA
- Experience working cross-functionally with manufacturing teams and suppliers
- Experience supporting U.S. product launches, post-market surveillance, complaints, and/or CAPAs
- Familiarity with statistical analysis tools (e.g., Minitab, JMP)
- Prior exposure to manufacturing or operations environments
- Exposure to serviceability, field support, or equipment maintenance considerations in product design
- Ability to work independently, manage priorities, and influence without direct authority
- Strong written and verbal communication skills
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Lead and support design quality and risk management activities, including DFMEA development and cross‑functional risk reviews
- Own and maintain elements of the Product Risk Management File throughout the product lifecycle
- Partner with R&D to embed quality and risk controls into system, hardware, and design requirements
- Translate design and CTQ requirements into robust manufacturing controls and inspection strategies, including hardware performance and safety requirements
- Collaborate with manufacturing teams to support design transfer, production readiness, and issue resolution
- Support supplier qualification and supplier quality activities, including design‑related inputs
- Support design quality activities for capital equipment and electromechanical systems, including hardware integration and system-level considerations
- Contribute to electrical safety and compliance activities (e.g., IEC 60601), including risk identification and test strategy alignment
- Partner with cross-functional teams to ensure serviceability, reliability, and field maintenance considerations are incorporated into product design
- Perform quality testing, statistical analysis, and root-cause investigations to address nonconformances and CAPAs
- Participate in design reviews, change management, and technical decision-making
- Support complaint investigations, post-market activities, and U.S. launch hyper-care efforts
Benefits
- 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
- Simple Steps (global well-being program)
- 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)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
