Hardware Engineer — Controller / Systems

Caldera Medical•Park City, UT

12d•Onsite

About The Position

Hardware Engineer — Controller / Systems Gynesis Platform — Neuromodulation Business Unit on site in Park City, Utah Caldera Medical’s Mission - To Improve the Quality of Life for Women! About Caldera Medical Caldera Medical is committed to improving the quality of life for women worldwide through innovative, minimally invasive pelvic health and neuromodulation solutions. Our Neuromodulation Business Unit is advancing the Gynesis platform, bringing a new generation of connected device technology to the clinicians and patients who rely on us. The Opportunity We're looking for a Hardware Engineer to bring additional engineering depth to the Gynesis platform during one of the most demanding stretches of the program. You'll own controller and systems execution alongside our current Engineering Lead and our external electrical-design partner, driving design transfer and verification & validation (V&V) through design freeze and our FDA 510(k) submission. This is a hands-on, high-visibility role at a critical inflection point — controller, garment/electrode, and QA workstreams are all converging toward freeze, and the program needs real engineering bench strength to execute cleanly through it.

Requirements

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.
BSEE/BSECE or equivalent.

Nice To Haves

NMES/electrostimulation or wearable electronics experience is a strong plus.

Responsibilities

Serve as Caldera's in-house owner of the Gynesis controller and systems engineering, partnering with our 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 our contract manufacturer, owning the supplier technical relationship and making the design production-ready.
Coordinate electrical interfaces across firmware, garment/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.