Electrical Engineer - Medical Devices & Regulatory

Phase2 Technology; Florham Park (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Phase2 Technology in Florham Park, NJ seeks an Electrical Engineer with 3–5 years in engineering or manufacturing to support medical device hardware and software development. You will handle design, verification, regulatory documentation, and collaboration across R&D, manufacturing and QA teams.

Responsibilities include PCB layout, schematics, test plans, device verification, and ensuring compliance with IEC 60601 family standards and FDA documentation.

Qualifications

• BS in Electrical Engineering with 3–5 years in engineering or manufacturing.
• ISO-13485, MDD and CSA requirements understanding.
• Experience with analog/digital and real-time embedded electronics.
• Familiarity with PCB fabrication and layout tools.

Responsibilities

• Knowledge of electronic design and software design with regulatory documentation background.
• IEC 60601 and IEC 60601-2 standards knowledge.
• System-level verification and validation testing experience.
• Familiarity with FDA Design History Files, Device Master Records and MDD files.
• Strong technical writing and MS Word/Excel/Visio/PowerPoint skills.
• Collaborate with Repair/Manufacturing to improve product quality and reliability.
• Develop and maintain manuals, test procedures and BOMs.
• Create PC board layouts, schematics and assemblies.
• Develop test plans for hardware/software verification & validation.
• Perform hardware/software verification and validation testing.
• Develop process control techniques for manufacturing.
• Create assembly procedures and provide training/oversight.
• Support R&D subassembly design, PCB layouts and testing.
• Verify manufacturability and quality with R&D.
• Support safety testing processes.

Skills

Analog/Digital embedded

Real-time embedded electronics

High-speed digital design

Communication skills

Technical writing

Oscilloscopes

Logic Analyzers

Processor emulators/debuggers

C language

C#

Visual Basic

MS Office

Testing protocols

Prioritization

Autonomy

Team collaboration

Education

BS in Electrical Engineering

Tools

ORCAD

PADS

SPICE

Job description

Phase2 Technology in Florham Park, NJ seeks an Electrical Engineer with 3–5 years in engineering or manufacturing to support medical device hardware and software development. You will handle design, verification, regulatory documentation, and collaboration across R&D, manufacturing and QA teams.

Responsibilities include PCB layout, schematics, test plans, device verification, and ensuring compliance with IEC 60601 family standards and FDA documentation.