Senior Hardware Engineer, Medical Devices
Core
Lead hardware design, development, and sustaining engineering for regulated medical devices, managing compliance, validation, and manufacturing support.
Role type
Senior Hardware Engineer (Medical Devices)
Builds
Regulated medical devices
Domain
Medical Devices / Hardware Engineering
Required skills
Analog, digital, and mixed-signal design; MCU, FPGA, and sensor interface design; Power electronics and DC-DC converters; High-speed PCB design (Ethernet, USB, SPI, I2C, CAN); DFM, DFT, SI/PI analysis; CAPA and change control; Obsolescence management; Component qualification; Hardware V&V; Risk management (dFMEA, pFMEA, sFMEA); Requirement traceability (RTM); Regulatory standards (IEC 60601-1, ISO 14971, ISO 13485); FDA regulations; Manufacturing transfer.
Preferred skills
IVD and clinical diagnostics; Cost reduction and VAVE; Safety and EMC compliance testing; Supplier qualification; Product lifecycle management; Agile/Scrum project delivery.
Technologies
Ethernet, FPGA, Firmware, Hardware Support
Responsibilities
Lead hardware design, development, and sustaining engineering; Manage CAPA, change processes, and obsolescence mitigation; Review schematics, component selections, and PCB designs; Carry out risk assessments, V&V, and compliance testing; Support manufacturing transfers and cost optimization; Collaborate with cross-functional teams.
Seniority
Senior, hands-on IC