Design Assurance Engineer / Medical Devices

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 TV 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

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., * 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

Nice to Have

• 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

Tech Breakdown 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.