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.