Senior Hardware Engineer
Posted 30 days ago · 0 applicants
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The role in plain words
This role involves leading the hands-on hardware design of a new medical device from initial concept through to production transfer. The day-to-day work includes schematic and board-level design, defining verification protocols, managing hardware-related risks, and coordinating with mechanical and software teams. You will also support compliance testing and resolve integration issues across different engineering disciplines.
- B.Sc./M.Sc. in Electrical/Electronics Engineering
- 7+ years of hands-on hardware design for complex products
- Demonstrated ownership through the full lifecycle: design, bring-up, verification, and transfer to production
- Direct experience writing and executing V&V protocols and performing system-level risk analysis
- Strong analog and mixed-signal foundation
- Concept-to-market and design-transfer experience
- Connectivity/interface depth (USB, UART, CAN, isolation, power systems)
Extracted from the job description · kept up to date automatically
Who this suits
This role suits an experienced electrical engineer with over seven years of hardware design experience, specifically including several years working on medical devices. It is less ideal for those who prefer to focus solely on board-level design without taking on system-level integration, risk management, and cross-functional coordination.
Full job description
Original listing · kept for referenceMedasense Biometrics is developing a new medical device and is looking for an experienced Senior Hardware Engineer to lead its hardware design, hands-on, from concept through verification and transfer to production. Beyond circuit and board design, the role owns the system-level responsibilities that make the hardware credible: design verification, risk management, and the interfaces toward the mechanical, sensing, and software/firmware teams.
Responsibilities
• Own analog and digital hardware design: schematic, board-level architecture, component selection, power, and signal integrity — through bring-up, debug, and design iteration.
• Define and execute design verification: test strategy, protocols, and acceptance criteria at both subsystem and system level.
• Lead hardware-related risk management (ISO 14971) — hazard analysis grounded in real failure modes — and contribute to the design history file under ISO 13485.
• Define electrical, sensing, power, and connectivity interfaces, and own the requirements toward software/firmware and mechanical teams.
• Drive cross-domain trade-offs (power, performance, cost, safety, manufacturability) and resolve integration issues across disciplines.
• Support compliance to IEC 60601-1 (and collaterals); coordinate with regulatory/QA and external test labs.
• Support manufacturing and field teams: design transfer, root-cause analysis, and design changes.
Requirements
• B.Sc./M.Sc. in Electrical/Electronics Engineering.
• 7+ years of hands-on hardware design for complex products, including several years in medical devices.
• Demonstrated ownership through the full lifecycle: design, bring-up, verification, and transfer to production — not design alone.
• Direct experience writing and executing V&V protocols and performing system-level (not only board-level) risk analysis.
• Strong analog and mixed-signal foundation; able to reason across mechanical and sensing domains.
• Comfortable owning the system seams, not only their own subsystem.
Advantage
• Patient monitoring, sensors, or physiological signal acquisition (PPG/biopotential/GSR or similar).
• Familiarity with IEC 60601-1, IEC 60601-2, ISO 14971, IEC 62366, and FDA design controls.
• Concept-to-market and design-transfer experience.
• Connectivity/interface depth (USB, UART, CAN, isolation, power systems).
Questions about this role
- This listing did not state a salary. We only show pay when the employer publishes it.
- B.Sc./M.Sc. in Electrical/Electronics Engineering, 7+ years of hands-on hardware design for complex products, Demonstrated ownership through the full lifecycle: design, bring-up, verification, and transfer to production, Direct experience writing and executing V&V protocols and performing system-level risk analysis, Strong analog and mixed-signal foundation