Senior Hardware Engineer
Core
Lead hardware design, development, and sustaining engineering for regulated medical devices.
Role type
Senior Hardware Engineer (Medical Devices)
Builds
Regulated medical devices
Domain
Medical Devices / Hardware Engineering
Required skills
Analog, digital, and mixed-signal electronics design; MCU, FPGA, and sensor interface design; Power electronics and DC-DC converters; High-speed PCB design (Ethernet, USB, SPI, I2C, CAN); PCB design, DFM, DFT, SI/PI analysis; Hardware verification and validation (V&V); Risk management (dFMEA, pFMEA, sFMEA); Requirement traceability (RTM); Component qualification and alternate-part evaluation; Manufacturing transfer and sustaining engineering.
Preferred skills
IVD, clinical diagnostics, or medical equipment experience; Cost reduction, VAVE, and should-cost analysis; Safety and EMC compliance testing; Supplier qualification and product lifecycle management; Agile or Scrum project execution.
Technologies
Ethernet, FPGA, Firmware, Hardware Support
Responsibilities
Lead hardware design, development, and sustaining engineering for regulated medical devices; Drive CAPA, change management, obsolescence mitigation, and product improvement initiatives; Conduct schematic reviews, select components, review PCB designs, and perform hardware validation; Carry out risk assessments, verification and validation, 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.
Seniority
Senior, hands-on IC