Design Quality Engineer II - Hardware (Surgical Robotics)

About the role

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.

Responsibilities

• Lead and support design quality and risk management activities, including DFMEA development and cross-functional risk reviews
• Possess 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
• Support 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

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
• Preferred: 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)
• Required: 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

Qualifications

• 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
• Preferred: 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)

Skills

• Design Quality Engineer II
• Quality Engineering
• Design Quality
• Manufacturing Quality
• Electrical Engineering
• Biomedical Engineering
• Capital Equipment
• Robotic Systems
• Minimally Invasive Surgery
• Risk Management
• DFMEA
• Supplier Quality
• Regulatory Compliance
• Statistical Analysis
• Serviceability
• Field Maintenance

Benefits

The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Pay

$79,200.00 - $118,800.00

Schedule

Minimum of 4 days per week onsite