Senior Hardware Engineer

A medical device company developing a connected, wearable neuromodulation platform, currently advancing the program through design freeze and FDA 510(k) submission.

We're looking for a Hardware Engineer to bring additional engineering depth to an active device platform during one of the most demanding stretches of the program. You'll own controller and systems execution alongside the current Engineering Lead and an external electrical-design partner, driving design transfer and verification & validation (V&V) through design freeze and FDA 510(k) submission.

This is a hands-on, high-visibility role at a critical inflection point — controller, wearable/electrode, and QA work streams are all converging toward freeze, and the program needs real engineering bench strength to execute cleanly through it.

• Serve as the in-house owner of controller and systems engineering for a connected wearable device, partnering with external electrical-design firm(s) to take the system to commercialization
• Author and maintain engineering requirements, design inputs/outputs, and test protocols, keeping them traceable to the FDA 510(k) submission
• Plan and execute verification & validation (V&V) — protocols, testing, and documented evidence — to demonstrate the device meets its requirements
• Lead design transfer to a contract manufacturer, owning the supplier technical relationship and making the design production-ready
• Coordinate electrical interfaces across firmware, wearable/electrode, and connector systems
• Drive electrical-safety, EMC, and applicable consensus-standard compliance testing, coordinating external test labs as needed
• Own engineering inputs and documentation in the Design History File (DHF) to audit-ready standards, and support design FMEAs/risk management with Quality
• Provide hands-on engineering depth on a fast-moving, high-visibility program, directing external EE firms and contract manufacturers
• Lead new hardware/systems development as additional indications and formats are pursued

• 7+ years of electrical/systems engineering experience in medical devices
• Embedded/firmware fluency, with hands-on design-transfer and V&V experience
• Comfort directing external EE firms and contract manufacturers
• NMES/electrostimulation or wearable electronics experience is a strong plus
• BSEE/BSECE or equivalent

This role adds critical engineering depth to an active program at its highest-load stretch — as controller, wearable, and QA work streams converge toward design freeze and 510(k) submission. You'll bring design-transfer and V&V rigor to a fast-moving program, and help build the engineering foundation for new indications and formats as the platform grows.

• Medical and dental benefits for employee and family members
• Vision coverage
• 401(k) with employer matching contributions