Hardware Engineer -- Controller / Systems

Job Description

Job Description

Hardware Engineer — Controller / Systems

Gynesis Platform — Neuromodulation Business Unit

**on site in Westlake Village, CA or 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.

What You'll Do

• 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.

Required Experience

• 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.

Why This Role Matters

This role adds critical engineering depth to the Gynesis program at its highest-load stretch — as controller, garment, and QA workstreams 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.

Competitive Compensation, Comprehensive Benefits, and more!

• 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.)

Our Culture- Where Career and Passion come together!

• 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!

Who is Caldera Medical?

Caldera Medical is dedicated to improving the quality of life for women through innovative surgical solutions for stress urinary incontinence, pelvic organ prolapse, polyps, and fibroids.

Our products are trusted by surgeons worldwide, and our commitment extends beyond medical advancements. We foster strong partnerships with surgeons and lead the largest humanitarian program in women’s health, aiming to provide treatment to one million underserved women by 2027.

Guided by integrity, we prioritize patients, customers, employees, and the community over profit. As the fastest-growing women’s health company, we remain committed to expanding education and access to life-changing care for women everywhere.

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.