Senior Medical Device NPD Engineer - PCB & Software

ElectroCore Inc; Rockaway Township (NJ); On-site; USD 120,000 - 170,000; Full time

Job summary

ElectroCore Inc is seeking an experienced engineer to design, develop, verify, and document Class II medical device hardware and software systems in New Jersey. The role requires hands‑on PCB development, embedded software coding and assembly, and the creation of regulator‑ready technical documentation.

You will execute verification protocols and reports, interpret IEC 60601-1, IEC 62304, and IEC 62366 standards, and contribute to design control activities throughout the product lifecycle.

Qualifications

• Bachelor’s degree in Electrical or Biomedical Engineering.
• 10+ years 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, ISO 14971).

Responsibilities

• Participate in development of new products and revisions to existing products according to company design control procedures.
• Support electrical and software development activities, including PCB design reviews, prototype builds, debugging, and firmware implementation.
• Develop, execute, and document verification protocols, test methods, and reports with full traceability to requirements.
• Create and maintain Design Control documents including design plans, specifications, risk analyses, verification protocols, and reports.
• Coordinate with internal and external resources, including third-party contractors, to support development activities.
• Participate in design reviews, risk reviews, and cross-functional technical discussions.
• Support manufacturing engineering during transfer-to-production, troubleshooting, and fixture development.
• Perform PCB-level troubleshooting using oscilloscopes, logic analyzers, and other diagnostic tools.
• Contribute to the Design History File (DHF), Device Master Record (DMR), and Risk Management File (RMF).

Education

Bachelor’s degree in Electrical Engineering or Biomedical Engineering

Tools

Oscilloscopes

Logic analyzers

Job description

ElectroCore Inc is seeking an experienced engineer to design, develop, verify, and document Class II medical device hardware and software systems in New Jersey. The role requires hands‑on PCB development, embedded software coding and assembly, and the creation of regulator‑ready technical documentation.

You will execute verification protocols and reports, interpret IEC 60601-1, IEC 62304, and IEC 62366 standards, and contribute to design control activities throughout the product lifecycle.