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.
Rate:
Not specified
Location:
Remote
IR35 Status:
Outside
Remote Status:
Remote
Industry:
Engineering
Seniority Level:
Mid-Level