Note: The job is a remote job and is open to candidates in USA. Dice is seeking an Electrical Engineer to support medical device development and regulatory compliance. The role focuses on electrical system design, IEC 60601 safety and EMC testing, EU MDR remediation, design verification, risk management, troubleshooting, and cross-functional collaboration.
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
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
- IEC 60601-1-2, EMC, CE Marking, FDA regulations, V&V, Technical Files, DHF, embedded systems, power electronics
Benefits
- Candidates can be Remote
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