EMI/EMC Test Engineer - Medical Devices
Department: Hardware Engineering / Regulatory & Compliance
Location: Glasgow, DE USA
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.
Required Qualifications
- Bachelor's degree in Electrical/Biomedical Engineering or related field
- 3 7 years of EMI/EMC experience, with at least 2+ years specific to medical devices
- Working knowledge of IEC 60601-1-2 and its test methods (IEC 61000-4 series as applied 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
- Ability to read schematics/PCB layouts, particularly isolation barriers and patient-applied parts
- Strong technical writing skills for regulatory-grade documentation
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
- Coordinate with accredited third-party test labs (e.g., UL, T V, Intertek) for formal IEC 60601-1-2 certification testing
- Author and maintain EMC test plans, protocols, and reports suitable for FDA 510(k)/PMA submissions and CE technical files (MDR)
- Link EMC test results to risk management file (ISO 14971) - document hazards, mitigations, and residual risk related to electromagnetic disturbances
- Recommend and validate design mitigations (shielding, filtering, grounding, isolation) without compromising patient safety or essential performance
- Support root-cause investigation for field complaints or CAPAs related to EMC issues
- Maintain traceability between EMC test evidence and Design History File (DHF) per IEC 62304/design control requirements
- Track evolving global regulatory requirements (FDA, EU MDR, Health Canada, etc.) affecting EMC for medical devices
Accliive, is an Engineering and IT Talent Services company working with Fortune 500 clients and is based out of Boston, MA. Accliive works extensively in all the major industries like Manufacturing, Semiconductor, Aerospace, BFSI, Oil and Gas, Utilities, Healthcare and many more. Acclive is focused on providing customer centric solutions and career centric solutions.
