Hiring: EMI/EMC Test Engineer in DE

Greetings from Centillion Infotech.

Currently we are hiring an EMI/EMC Test Engineer for one of our clients in Glasgow, DE.

EMI/EMC Test Engineer

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, 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)

Centillion Infotech LLC is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national origin or citizenship status or ethnic origin, disability, marital status, veteran status or any other occupationally irrelevant criteria.