EMI/EMC Test Engineer - Medical Devices
Department: Hardware Engineering / Regulatory & Compliance
Location: Glasgow, DE,USA
Employment Type: Full-Time / Contract
No of Position:01
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
- 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
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
Preferred Qualifications
- Experience supporting FDA 510(k) or PMA submissions, or EU MDR technical documentation
- Familiarity with ISO 14971 (risk management) and IEC 62304 (software lifecycle, if device includes firmware)
- Experience with wireless coexistence testing for connected/IoT medical devices
- Exposure to home-use/lay-person environment EMC (IEC 60601-1-11)
- Familiarity with EMC simulation tools (ANSYS HFSS, CST)
Soft Skills
- Comfortable working within a regulated, design-controlled environment (documentation discipline, traceability)
- Strong cross-functional collaboration with regulatory affairs, quality, and systems engineering
- Able to communicate EMC risk clearly to non-EMC stakeholders (e.g., regulatory, clinical teams)