New Product Development Engineer – Medical Devices

Engineering Resource Group, Inc.; Dover (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Engineering Resource Group, Inc. seeks a Senior Electrical Engineer for new product development of medical devices.

This permanent role (also possible contract) involves designing hardware and embedded software under design controls and supporting PCB development through reviews, prototyping, debugging and firmware implementation. You will troubleshoot at board level with bench instruments, create verification protocols and risk analyses, and serve as technical lead during FDA inspections,

Qualifications

• Senior level role with 10+ years in medical device product development.
• Hands-on PCB design, assembly and debugging experience.
• Experience with embedded software development.
• Regulatory requirements knowledge (FDA, EU MDR) and design control.
• Ability to lead during FDA inspections and audits.

Responsibilities

• Design, develop and verify device hardware and embedded software under design controls.
• Support PCB development through design reviews, prototyping, debugging and firmware implementation.
• Write verification protocols, test methods and reports with traceability to requirements.
• Coordinate design and risk reviews with quality, regulatory, manufacturing and third-party contractors.
• Serve as technical lead during FDA inspections and audits.

Skills

Embedded software

PCB design

Diagnostics with scopes

Regulatory knowledge

FDA audits

Education

BS Electrical Engineering

Biomedical Engineering

Job 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.
• 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.