Sr. New Product Development (NPD) Engineer
On-siteRockaway, New Jersey, United States
Job Summary
Lead design, development, and verification of Class II medical device hardware and software systems, including PCB design reviews, prototype builds, and firmware implementation. Execute verification protocols and reports with full traceability to requirements while creating and maintaining Design Control documents such as design plans, specifications, risk analyses, and the Design History File. Interpret and apply regulatory standards including IEC 60601-1, IEC 62304, and IEC 62366 to ensure compliance with Quality Management System requirements for Design Control and Risk Management. Coordinate with internal and external resources, including third-party contractors, and participate in design reviews, risk reviews, and cross-functional technical discussions. Support manufacturing engineering during transfer-to-production, troubleshooting, and fixture development.
Required Qualifications
- Bachelor's degree in Electrical Engineering, Biomedical Engineering, or related technical field
- +10 years of experience in Class II medical device product development or related engineering role
- Hands-on experience with PCB design, assembly, debugging, and embedded software development
- Demonstrated ability to create technical documents, verification protocols, and engineering reports
- Experience with domestic and international medical device regulatory requirements; IEC 60601-1, IEC 62304, IEC 62366, and ISO 14971
- Strong attention to detail
- Excellent written and verbal communication skills
- Ability to interpret complex standards and translate them into engineering and product requirements
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