Manager Medical Device Software Engineer Jobs in Orem, UT

Job Description
Firmware / Backend Software Engineer
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 Firmware & Backend Software Engineer to take ownership of the Gynesis platform's device firmware and back-end software in-house. This is a foundational role: firmware is regulated device software under our FDA 510(k) submission, and clean, well-documented, in-house-owned software is central to both getting this platform to market and building what comes after it.
You'll own the controller firmware, the host-side data-extraction tool, and the accessory app's backend - establishing the source ownership, documentation, and architecture discipline that carries Gynesis through submission and lays the foundation for our next-generation wireless (BLE) roadmap.
What You'll Do
• Own the Gynesis device firmware in-house - waveform control, button/display logic, USB-C and power management - developed to IEC 62304.
• Produce submission-grade software documentation, a software bill of materials (SBOM), and cybersecurity artifacts to support our FDA 510(k) submission.
• Establish clean in-house source ownership, version control, and build processes, closing gaps left by prior development vendors.
• Author software requirements, architecture, and test protocols traceable to the submission.
• Ensure all software work meets FDA premarket cybersecurity, IEC 62304, and design-control expectations, partnering closely with Regulatory and Quality.
• Collaborate with the controller/hardware engineer on firmware-hardware integration and data interfaces.
• Lay the software architecture foundation for our next-generation wireless (BLE) device, companion app, and provider portal.
• Own the backend infrastructure supporting the accessory app, including authentication, data, APIs, and push notifications.
Required Experience
• 7+ years of embedded firmware (C/C++) and back-end/server-side software development experience.
• Experience with medical device software developed under IEC 62304, including cybersecurity and FDA software documentation.
• A track record of owning firmware↔host data interfaces and application backends (authentication, APIs, data).
• BLE/wireless development experience, and interest in helping architect our wireless V2 roadmap, is a strong plus.
Why This Role Matters
This role sits at the center of Gynesis's path to market. You'll bring source ownership, documentation, and cybersecurity rigor in-house, directly supporting our FDA submission - and you'll help set the technical foundation for the wireless, connected products that come next.
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.