EMIEMC Test Engineer

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 IECand 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

• Bachelors degree in Electrical/Biomedical Engineering or related field
• 37 years of EMI/EMC experience with at least 2 years specific to medical devices
• Working knowledge of IECand 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(radiated/conducted emissions radiated/conducted immunity ESD EFT/burst surge magnetic field immunity dips & interruptions)
• Apply collateral/particular standards as applicable (e.g. IECfor home healthcare environments IECXX 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 TÜV Intertek) for formal IECcertification 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 Experience:

IC