Design Assurance Engineer​/Medical Devices

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.

• 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 TÜV and Intertek
• Exposure to lasers, optics, and photonics is a plus

• 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

• 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
• Strong communication and documentation skills
• Proficiency with Microsoft Word and Excel

• FDA QSR experience
• ISO 13485 and ISO 14971
• IEC 60601, IEC 60825, IEC 62366, or IEC 62304
• IQ/OQ/PQ experience
• FDA or CE submission experience
• Minitab or other statistical software
• DOE, ANOVA, Gage R&R, or capability analysis
• Experience with lasers, optics, or photonics

• 30% — Design Controls & Risk Management
• 25% — Verification & Validation
• 20% — Regulatory & Compliance
• 15% — Technical Documentation
• 10% — Statistical Analysis & Testing

Applicants must be currently authorized to work in the U.S. on a full-time basis now and in the future.

Posted By:
Ava Fraulo