Hardware Engineer — Controller ​/ Systems

Hardware Engineer — Controller / Systems Gynesis Platform — Neuromodulation Business Unit

on site in Park City, Utah

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.

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 work streams are all converging toward freeze, and the program needs real engineering bench strength to execute cleanly through it.

• 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.

• 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 the Gynesis program at its highest-load stretch — as controller, garment, 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 4% matching contributions after 90 days of employment
• Basic Life and AD&D
• Unlimited Vacation Policy
• 6 Weeks Paid Maternity Leave
• 10 paid holidays
• Being surrounded by amazing people!

(This role is being filled directly by our in-house recruiting team. We are not working with outside agencies for this position.)

• A Culture of family and team… not a corporate goliath where you’re just another number.
• All employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.
• The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.
• Our goal is to treat 1 million women suffering from incontinence by 2027!

Caldera Medical is dedicated to improving the quality of life for…