Regulatory Test Engineer

Design & Development:

• Develop schematic designs and multi-layer PCB layouts for analog, digital, and mixed-signal circuits using tools like Altium Designer or OrCAD.
• Select electronic components based on performance, cost, and medical-grade reliability.
• Perform circuit simulations and power integrity analysis to ensure design robustness.

Testing & Validation:

• Execute Verification and Validation (V&V) protocols for Class II and Class III medical devices.
• Conduct electrical safety and performance testing according to IEC 60601-1 standards.
• Perform root cause analysis and failure investigations (FMEA/Hazard Analysis) for technical issues.

Required Skills & Qualifications

• Education: Bachelor s or Master s degree in Electronics, Electrical, or Biomedical Engineering.

Technical Hard Skills:

• Proficiency in Product design PCB design software and circuit simulation tools (e.g., SPICE).
• Testing Tools : Hands-on experience with lab equipment: Oscilloscopes, Spectrum Analyzers, and Signal Generators.

Adds Advantage

• Regulatory Knowledge: Deep understanding of IEC 62304 (Medical Device Software).
• Worked on medical devices ,Design ,Testing .