Electrical Engineer - Medical Device

Electrical Engineer – Medical Devices
Location: Denver, CO | Candidates can be Remote

We are seeking an Electrical Engineer with medical device experience and hands-on knowledge of EU MDR and IEC 60601 compliance.

Key Responsibilities:
• Design and evaluate electrical systems/circuits for medical devices.
• Perform and document IEC 60601-1 electrical safety testing.
• Conduct leakage current, ground continuity, hipot, insulation resistance, and single-fault testing.
• Support EU MDR 2017/745 remediation, technical files, and DHF documentation.
• Support IEC 60601-1-2 EMC testing and compliance.
• Perform design verification, troubleshooting, failure analysis, and root cause investigations.
• Support ISO 14971 risk management and Design Controls.
• Collaborate with Quality, Regulatory, R&D, Manufacturing, test labs, and Notified Bodies.

Required Skills:
• Bachelor’s in Electrical Engineering or related field.
• 3+ years of medical device or regulated-industry experience.
• Hands-on IEC 60601-1 testing experience.
• Knowledge of EU MDR 2017/745.
• Experience with ISO 14971, ISO 13485, and Design Controls.
• Ability to interpret electrical schematics and test requirements.
• Strong troubleshooting and technical documentation skills.

Additional Skills: IEC 60601-1-2, EMC, CE Marking, FDA regulations, V&V, Technical Files, DHF, embedded systems, power electronics.