Software Engineer - Firmware / Backend

Caldera Medical

$108K — $130K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 7+ years of embedded firmware (C/C++) and backend software development experience.
  • Experience in medical device software under IEC 62304, focusing on cybersecurity and FDA documentation.
  • Proven ability to manage firmware-host data interfaces and application backends, including authentication and APIs.
  • Familiarity with BLE/wireless development, contributing to the architecture of future wireless products is advantageous.
  • Strong documentation skills for developing submission-grade software artifacts.

Responsibilities

  • Own the Gynesis device firmware, including waveform control and power management, following IEC 62304 standards.
  • Produce software documentation and artifacts for FDA 510(k) submission.
  • Implement in-house source ownership and establish version control/build processes.
  • Draft software requirements and test protocols linked to regulatory submissions.
  • Ensure compliance with FDA premarket cybersecurity and design controls, collaborating with Regulatory and Quality teams.
  • Cooperate with hardware engineers on firmware and hardware integration and data interfaces.
  • Develop backend infrastructure for the accessory app, encompassing authentication, data management, and API integration.

Benefits

  • 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
  • Positive and collaborative work environment.
Full Job Description
Job Description

Firmware / Backend Software Engineer

Gynesis Platform - Neuromodulation Business Unit

**on-site in Park City, Utah**

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 firmware1host 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.)

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