EMI/EMC Test Engineer - Medical Devices (Regulatory)

Zodiac Solutions; Newark (DE); On-site; USD 90,000 - 130,000; Full time

Job summary

Zodiac Solutions in Newark, DE, is seeking an EMI/EMC Test Engineer for medical devices to own EMC testing and regulatory submissions. The role partners with R&D, regulatory affairs, and systems engineering to mitigate EMC risks across the design lifecycle, including clinical and home-use environments.

The candidate will conduct pre- and full-compliance testing, coordinate with labs, and author test plans and reports for FDA 510(k)/PMA submissions and CE files.

Qualifications

• Bachelor's degree in Electrical/Biomedical Engineering or related field is required.
• 3-7 years of EMI/EMC experience, with at least 2+ years in medical devices.
• Understanding of IEC 60601-1-2 and IEC 61000-4 series as applied to medical devices.
• Experience with EMC test equipment and ability to read schematics/PCB layouts.

Responsibilities

• Plan, execute, and analyze EMC pre- and full-compliance testing per IEC 60601-1-2.
• Apply collateral standards like IEC 60601-1-11 for home healthcare environments.
• Support wireless coexistence testing for BLE and Wi-Fi per FDA guidance.
• Conduct EMC design reviews at schematic, PCB, cable/harness, and enclosure stages.
• Debug EMC failures using spectrum analyzers, EMI receivers, near-field probes, ESD devices, and surge generators.
• Coordinate with third-party labs for IEC 60601-1-2 certification testing.
• Author and maintain EMC test plans, protocols, and reports for FDA submissions and CE files.
• Link EMC test results to ISO 14971 risk management file.

Skills

EMC Testing

Reading schematics

Test equipment proficiency

Education

Bachelor's degree in Electrical/Biomedical Engineering

Tools

EMI receivers

Spectrum analyzers

ESD guns

Surge/EFT/burst generators

Near-field probes

Job description

Zodiac Solutions in Newark, DE, is seeking an EMI/EMC Test Engineer for medical devices to own EMC testing and regulatory submissions. The role partners with R&D, regulatory affairs, and systems engineering to mitigate EMC risks across the design lifecycle, including clinical and home-use environments.

The candidate will conduct pre- and full-compliance testing, coordinate with labs, and author test plans and reports for FDA 510(k)/PMA submissions and CE files.