A leading global technology company is looking for a Design Assurance Engineer to join its team in Marlborough, MA.
This is a great opportunity for an engineer with 3-5 years of medical device experience who wants to take on meaningful work across the full product development lifecycle. You’ll help develop and improve Class II electro-mechanical medical devices while working closely with Design Engineering, Quality, Regulatory, and external testing teams.
You’ll have the opportunity to work on products from early design and risk assessment through verification, validation, compliance testing, and commercialization.
Why This Role?
Work on advanced Class II electro-mechanical medical devices
Be involved throughout the full product development lifecycle
Work closely with Engineering, Quality, and Regulatory teams
Take ownership of design assurance, risk management, V&V, and compliance activities
Gain exposure to FDA, CE, ISO, and IEC requirements
Work with external testing organizations including TUV and Intertek
Exposure to lasers, optics, and photonics is a plus
What You’ll Be Doing
Support design control and risk management activities
Perform and support DFMEA and PFMEA activities
Develop and execute verification and validation protocols
Support IQ/OQ/PQ and other validation activities
Coordinate EMC, EMI, and IEC compliance testing
Work with external test laboratories
Maintain design history files and technical documentation
Support FDA, CE, and other regulatory submissions
Analyze test data and help engineering teams make design decisions
Collaborate with Design Engineering, Quality, Regulatory, and external partners
What We’re Looking For
Bachelor’s degree in Electrical Engineering, Engineering, or a related scientific field
3-5 years of Class II medical device experience
Experience with Design Controls and Risk Management
Experience with verification and validation
Experience with EMC, EMI, and IEC compliance testing
Experience with DFMEA/PFMEA and technical documentation