Senior Medical Device NPD Engineer - Hardware & Embedded

Engineering Resource Group, Inc.

Dover (NJ)

On-site

USD 120,000 - 180,000

Full time

3 days ago

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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.