EMI/EMC Test Engineer – Medical Devices

Zapnix LLC; Nürnberg; Vor Ort; EUR 78.000 - 112.000; Vollzeit

Zusammenfassung

Zapnix LLC is hiring EMI/EMC Test Engineer for a leading medical device client. The role focuses on planning and executing EMC pre-compliance and compliance testing in line with IEC 60601-1-2 and related standards.

You will troubleshoot, review schematics, and coordinate with accredited labs to ensure regulatory readiness. The successful candidate will support FDA 510(k)/PMA and EU MDR submissions and maintain accurate test documentation.

Jobbeschreibung

We are hiring for our client, a leading organization in the medical device industry, and looking for an experienced EMI/EMC Test Engineer to join their Hardware Engineering / Regulatory & Compliance team.

Location: Glasgow, DE, USA

Employment Type: Full-Time / Contract

Key Responsibilities

• Plan and execute EMC pre-compliance and compliance testing per IEC 60601-1-2.
• Perform radiated/conducted emissions, immunity, ESD, EFT, surge, and related testing.
• Troubleshoot EMC failures using EMI receivers, spectrum analyzers, near-field probes, ESD/EFT equipment, etc.
• Review schematics, PCB layouts, cables, grounding, shielding, filtering, and isolation.
• Coordinate with accredited EMC labs such as UL, TÜV, and Intertek.
• Prepare EMC test plans, protocols, reports, and regulatory documentation.
• Support FDA 510(k)/PMA and EU MDR submissions and ISO 14971 risk management.

Required Qualifications

• Bachelor's degree in Electrical, Electronics, Biomedical Engineering, or related field.
• 3–7 years of EMI/EMC experience, including 2+ years in medical devices.
• Strong knowledge of IEC 60601-1-2 and IEC 61000-4 standards.
• Hands-on EMC testing and troubleshooting experience.Ability to review schematics and PCB layouts.
• Strong technical documentation and communication skills.

Preferred Qualifications

• FDA 510(k)/PMA or EU MDR experience.
• ISO 14971 / IEC 62304 knowledge.
• Wireless coexistence testing experience with Wi-Fi/BLE.
• Experience with ANSYS HFSS or CST.