Must-Have Skills 10+ years of experience in Medical Device Hardware Development Analog, Digital & Mixed-Signal Design MCU, FPGA, Sensor Interface Design Power Electronics, Battery-Powered Devices, DC-DC Converters High-Speed PCB Design (Ethernet, USB, SPI, I2C, CAN) PCB Design, DFM, DFT, SI/PI Analysis CAPA, NCR, Change Control & Obsolescence Management Component Qualification & Alternate Part Evaluation Hardware Verification & Validation (V&V) Risk Management (dFMEA, pFMEA, sFMEA) Requirement Traceability (RTM) IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485 FDA Medical Device Regulations Manufacturing Transfer & Sustaining Engineering Windchill / Agile PLM Key Responsibilities Lead hardware design, development, and sustaining engineering activities for regulated medical devices.
Drive CAPA, change management, obsolescence mitigation, and product improvement initiatives. Perform schematic reviews, component selection, PCB design reviews, and hardware validation. Execute risk assessments, V&V, compliance testing, and regulatory support activities. Support manufacturing transfers, supplier changes, and cost optimization programs. Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.