Lead Electrical Engineer I in Bangalore, भारत

Beckman Coulter Diagnostics seeks a Lead Electrical Engineer to design and validate PCB hardware for laboratory diagnostic medical devices. This R&D role involves developing regulated medical device platforms, managing hardware subsystems from concept through release, and ensuring compliance with IEC and FDA standards.

Responsibilities

• Design and validate high-density, multi-layer PCBs with analog/digital/mixed-signal circuits for diagnostic instruments
• Own hardware development lifecycle from architecture through release, including power management and microcontroller-based subsystems
• Ensure designs meet IEC 60601, ISO 13485, and FDA requirements via testing coordination and design updates
• Lead technical investigations of field failures and manufacturing issues; manage CAPA pipeline using structured methodologies
• Collaborate across teams to resolve manufacturing and field problems through feasibility studies and design reviews

Requirements

• Bachelor's and Master's degree in Electrical or Electronics Engineering
• 8+ years of medical or industrial-grade PCB hardware development experience
• Proficiency with EDA tools: OrCAD, Altium, PADS, PSpice, or LTspice
• Deep knowledge of IEC 60601, ISO 13485, FDA Class I/II regulations and EMI/EMC standards
• Hands-on expertise with oscilloscopes, spectrum analyzers, logic analyzers, and advanced lab equipment
• Experience leading CAPA investigations using structured problem-solving frameworks
• Cross-functional communication skills and regulatory documentation expertise