Find & Apply For Product Development Engineer Jobs in Dover, New Jersey

Description Permanent position for a Senior Electrical Engineer for new product development of medical devices. This can also be a contract/temp position position if desired. Design, develop and verify device hardware and embedded software under design controls, for new products and revisions to existing ones. Support PCB development through design reviews, prototype builds, debugging and firmware implementation. Troubleshoot at the board level using oscilloscopes, logic analyzers and other bench instrumentation. Write and execute verification protocols, test methods and reports with full traceability to requirements. Responsible for design control deliverables including design plans, specifications, risk analyses and DHF, DMR and RMF content. Translate IEC requirements into engineering and product requirements. Serve as technical lead during FDA inspections and audits. Support transfer to production, manufacturing troubleshooting and test fixture development. Coordinate design and risk reviews with quality, regulatory, manufacturing and third-party contractors. Requirements BS Electrical Engineering or Biomedical Engineering (or related technical field). Minimum 10 years of experience in medical device product development or a related engineering role. Hands-on experience with PCB design, assembly and debugging. Experience with embedded software development. Experience writing verification protocols, test reports and regulator-ready technical documentation. Experience with domestic and international medical device regulatory requirements (FDA, EU MDR, etc.). Proficiency with oscilloscopes, logic analyzers and general bench test equipment. #ERGx