EMI/EMC Test Engineer
LocationGlasgow, Delaware, United States
Typefull-time
SeniorityMid
Experience3–7 yrs
Company size1,001–5,000 people
PostedSep 9, 2026 · 1mo ago
Verified live1d ago
At a glanceSummarised by Seekless from the posting.
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
Skills
EMI receivers
spectrum analyzers
ESD guns
surge/EFT/burst generators
near-field probes
BLE
Wi-Fi
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.
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
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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, TÜV, Intertek) for formal IEC 60601-1-2 certification testing
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Author and maintain EMC test plans, protocols, and reports suitable for FDA 510(k)/PMA submissions and CE technical files (MDR)
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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
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