Design Quality Engineer II (Hardware)

TL;DR

Design Quality Engineer II (Hardware): Supporting design quality, risk management, and U.S. launch of innovative surgical robotics systems with an accent on hardware performance, electrical safety, and capital equipment reliability. Focus on translating design requirements into robust manufacturing controls, performing root-cause investigations, and ensuring compliance with medical device standards.

Location: Must be based in North Haven, Connecticut; onsite 4 days per week.

Salary: $79,200–$118,800

Company

A global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Lead design quality and risk management activities, including DFMEA development.
• Partner with R&D to embed quality and risk controls into system and hardware requirements.
• Translate design and CTQ requirements into robust manufacturing controls and inspection strategies.
• Collaborate with manufacturing teams to support design transfer and production readiness.
• Contribute to electrical safety and compliance activities, including IEC 60601 alignment.
• Perform statistical analysis and root-cause investigations to address nonconformances and CAPAs.

Requirements

• Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related hardware-focused discipline.
• 2+ years of related work experience (or Master’s degree with 0–2 years).
• Must possess unrestricted U.S. work authorization at the time of hire.
• Must be able to work onsite in North Haven, CT, 4 days per week.
• Experience with design risk management and cross-functional collaboration.
• Strong written and verbal communication skills.

Nice to have

• Experience with capital equipment or complex electromechanical medical devices.
• Background in regulated industries like medical devices, robotics, or aerospace.
• Familiarity with statistical analysis tools such as Minitab or JMP.
• Exposure to serviceability, field support, or equipment maintenance considerations.

Culture & Benefits

• Competitive salary and short-term incentive plans.
• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and well-being programs.