Job Description & Details
This is a heavy-hitting hardware role deeply rooted in the medical device sector where regulatory compliance matters just as much as clean schematic design. You will be architecting and sustaining complex life-saving equipment, meaning your design choices directly impact patient safety and FDA approvals.
What You'll Actually Be Doing
Your day-to-day will involve everything from pure analog and digital mixed-signal design to chasing down obscure noise issues on high-speed PCBs. You'll spend a significant amount of time wading through IEC and ISO standards, managing component obsolescence, and steering hardware through the grueling FDA regulatory gauntlet. Expect to bridge the gap between initial prototyping and full-scale manufacturing transfer while collaborating heavily with firmware and quality teams.
The Core Tech Stack
You absolutely need a rock-solid foundation in analog, digital, and mixed-signal design paired with hands-on experience on MCUs, FPGAs, and sensor interfaces. Mastery over high-speed PCB design protocols like USB, Ethernet, SPI, I2C, and CAN is non-negotiable here, alongside a deep understanding of power electronics and DC-DC converters. Familiarity with PLM systems like Windchill or Agile is heavily leaned upon to keep documentation audit-ready.
Interview Expectations
Be prepared for deep technical grilling on risk management, specifically walking through a dFMEA scenario where a critical component went obsolete and you had to qualify an alternate part under strict regulatory constraints. They will also test your practical knowledge of SI/PI analysis and high-speed layout strategies, wanting to hear how you mitigate EMI issues to pass rigorous IEC 60601-1-2 EMC testing on the first try.
Application Advice
Do not just list your technical skills; highlight your direct experience navigating FDA regulations, ISO 13485, and risk management frameworks like ISO 14971 right at the top of your resume. Ensure keywords like CAPA, V&V, DFM, and mixed-signal design are prominent so you immediately clear the ATS screening by signaling that you speak the language of regulated medical manufacturing.