An Electrical Engineer with experience in R&D of electro-mechanical medical devices, who understands mixed-signal circuit design, EMC/product safety standards, and design control in an FDA environment.
1. EMC and Product Safety Compliance (IEC/UL/CSA Standards)
• Hands-on experience with EMC test planning, execution, and troubleshooting
• Familiarity with relevant standards: IEC/EN 61326-1, IEC/EN 61010, UL/CSA/IEC 60950, IEC 62368-1
2. Mixed-Signal Circuit Design (Analog + Digital)
• Strong foundation in analog/digital circuit design, simulation, and analysis
• Proficiency with tools such as OrCAD Capture, PSpice, and Mentor Graphics PADS
3. Electro-Mechanical Medical Device Development (Full Product Lifecycle)
• Experience in end-to-end development: feasibility, prototyping, V&V
• Cross-functional collaboration with R&D, QA, Regulatory, and external test labs
• Background in FDA-regulated (IVD/medical device) environments
4. Verification, Validation & CAPA Documentation
• Proven ability to write/execute V&V protocols, develop test methods, and support CAPA investigations
• Knowledge of FDA Quality Systems (21 CFR 820) and design control requirements
5. System-Level Thinking with EMC/Safety Focus
• Experience leading system-level EMC/safety risk assessments and offering design guidance
• Involvement with external certification processes: UL, CE Marking, CB Scheme
• Effective interfacing with certification agencies and test labs