EMI/EMC Test Engineer Medical Devices

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.

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, TV, 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)