Software Engineer — Firmware / Backend

Caldera Medical•Park City, UT

5d•Onsite

About The Position

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.

Requirements

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).

Nice To Haves

BLE/wireless development experience, and interest in helping architect our wireless V2 roadmap, is a strong plus.

Responsibilities

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.