EMI/EMC Test Engineer — Medical Devices
Full-time
Transcend Softech LLC
Position: EMI/EMC Test Engineer (Medical Devices)
Location: New Castle, DE
Employment Type: Full-Time / Contract
Job Summary
We are seeking an EMI/EMC Test Engineer to own electromagnetic compatibility and electromagnetic interference testing for our medical device portfolio, ensuring compliance with IEC 60601-1-2 and supporting FDA/international regulatory submissions. The role works closely with R&D, systems engineering, and regulatory affairs to identify and mitigate EMC risks throughout the design lifecycle, particularly for devices operating in clinical and home-use environments.
Key Responsibilities
- Plan, execute, and analyze EMC pre-compliance and full-compliance testing per IEC 60601-1-2 (radiated/conducted emissions, radiated/conducted immunity, ESD, EFT/burst, surge, magnetic field immunity, dips & interruptions)
- Apply collateral/particular standards as applicable (e.g., IEC 60601-1-11 for home healthcare environments, IEC 60601-2-XX device-specific standards)
- Support wireless coexistence testing for connected medical devices (BLE, Wi-Fi) per FDA guidance on RF wireless technology
- Conduct EMC design reviews at schematic, PCB layout, cable/harness, and enclosure stages - especially around patient-connected circuits and isolation boundaries
- Debug EMI/EMC failures using spectrum analyzers, EMI receivers, near-field probes, ESD simulators, and surge/EFT generators
Required Qualifications
- Bachelor's degree in Electrical/Biomedical Engineering or related field
- 3 7 years of EMI/EMC experience
- Minimum 2+ years specific to medical devices
- Understanding of "essential performance" and "basic safety" concepts as they relate to EMC pass/fail criteria
- Experience with EMC test equipment: EMI receivers, spectrum analyzers, ESD guns, surge/EFT/burst generators, near-field probes
Vacancy posted 2 days ago
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