EMI/EMC Test Engineer Medical Devices | Full-Time / Contract | Glasgow, DE (Onsite)

EMI/EMC Test Engineer Medical Devices

Location: Glasgow, DE (Onsite)
Job Type: Full-Time / Contract
Experience: 3 7 Years
Industry: Medical Devices / Healthcare

Job Summary

We are seeking an experienced EMI/EMC Test Engineer to support electromagnetic compatibility and electromagnetic interference testing for regulated medical devices. The ideal candidate will have hands-on experience with IEC 60601-1-2, EMC test methods, troubleshooting, compliance documentation, and medical-device regulatory requirements.

This position will work closely with Hardware Engineering, R&D, Systems Engineering, Quality, and Regulatory teams to identify and mitigate EMC risks throughout the product development lifecycle.

Key Responsibilities

• Plan, execute, analyze, and document EMI/EMC testing for medical devices in accordance with IEC 60601-1-2.
• Perform radiated and conducted emissions and immunity testing, including ESD, EFT/burst, surge, magnetic-field immunity, voltage dips, and interruptions.
• Apply applicable collateral and particular standards, including relevant IEC 61000-4 series requirements.
• Support EMC testing for connected medical devices using wireless technologies such as Wi-Fi and Bluetooth/BLE.
• Conduct EMC design reviews covering schematics, PCB layouts, cable/harness designs, enclosures, patient-connected circuits, and isolation boundaries.
• Troubleshoot EMC failures using spectrum analyzers, EMI receivers, near-field probes, ESD simulators, surge/EFT generators, and related test equipment.
• Develop and validate EMC mitigation strategies including shielding, filtering, grounding, and isolation.
• Coordinate with accredited third-party laboratories during formal compliance and certification testing.
• Develop and maintain EMC test plans, protocols, reports, and supporting technical documentation.
• Support regulatory documentation for FDA submissions and international regulatory/technical files.
• Link EMC test results and mitigations to product risk-management documentation in accordance with ISO 14971.
• Support investigations and CAPA activities related to EMC/EMI issues and field complaints.
• Maintain appropriate traceability between EMC evidence and design-control/product documentation.
• Support compliance activities for products intended for clinical and home-use environments.
• Monitor applicable changes in global EMC and medical-device regulatory requirements.

Required Qualifications

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, Electronics Engineering, or a related discipline.
• 3 7 years of experience in EMI/EMC engineering or testing.
• At least 2 years of experience working with medical devices or regulated healthcare products preferred.
• Strong working knowledge of IEC 60601-1-2 and applicable EMC test methods.
• Experience with relevant IEC 61000-4 series testing.
• Hands-on experience with EMC test equipment such as:
  • EMI receivers
  • Spectrum analyzers
  • ESD simulators
  • EFT/Burst generators
  • Surge generators
  • Near-field probes
• Ability to read and evaluate electrical schematics and PCB layouts.
• Understanding of isolation barriers, patient-applied parts, basic safety, and essential performance.
• Strong technical writing and documentation skills.

Preferred Qualifications

• Experience supporting FDA 510(k), PMA, EU MDR, or similar regulatory submissions.
• Familiarity with ISO 14971 risk management.
• Knowledge of IEC 62304 for products incorporating software/firmware.
• Experience with wireless coexistence testing involving Wi-Fi, Bluetooth, or BLE.
• Experience with home-use medical devices and IEC 60601-1-11.
• Familiarity with EMC simulation tools such as ANSYS HFSS or CST.
• Experience coordinating testing with accredited laboratories.
• Experience supporting CAPA, failure investigations, and design-change activities.

Soft Skills

• Strong analytical and problem-solving abilities.
• Excellent documentation and communication skills.
• Ability to work effectively in a regulated, design-controlled environment.
• Strong collaboration skills with Engineering, Quality, Regulatory, and Systems teams.
• Ability to communicate EMC risks and technical findings to both technical and non-technical stakeholders.