Software Engineer — Firmware / Backend

About the role

The Firmware / Backend Software Engineer will own the Gynesis platform's device firmware and back-end software in-house. This role is foundational, with firmware regulated under FDA 510(k) submission and clean, documented, in-house-owned software critical for market entry and future product development.

Responsibilities

• Own the Gynesis device firmware, including waveform control, button/display logic, USB-C and power management, developed to IEC 62304.
• Produce submission-grade software documentation, SBOM, and cybersecurity artifacts to support 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, collaborating 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.

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

Qualifications

• Strong understanding of medical device software development lifecycle.
• Experience with medical device regulatory compliance and documentation.
• Knowledge of IEC 62304 standards for medical device software.
• Proficiency in C/C++ programming languages.
• Experience with version control systems like Git.
• Excellent communication and collaboration skills.

Skills

• Embedded firmware development (C/C++)
• Backend server-side software development
• Medical device software development
• IEC 62304 compliance
• Wireless development (BLE)

Benefits

• Competitive compensation
• Comprehensive benefits package
• Medical and dental benefits for employee and family members
• Vision coverage
• 401(k) with 4% matching contributions after 90 days of employment
• Unlimited vacation policy
• 6 weeks paid maternity leave
• 10 paid holidays

Pay

Competitive compensation details will be provided during the interview process.

Schedule

The role is on-site in Park City, Utah.