Firmware/Software Technical Lead - Medical Devices

NIRSense is a cardiology company focused on developing world-leading non-invasive medical devices. Our tools measure oxygenation changes in the body 10x deeper than typical pulse oximetry and track the electrophysiological activity of muscles and the brain. We are a growing team of technology developers seeking candidates interested in helping advance our capabilities for a wide range of interested stakeholders who are driven to transform the way humans understand and interact with their own health.

NIRSense is seeking a hands-on Technical Lead to join our multidisciplinary team in developing firmware and supporting application software for cutting-edge wearable medical devices. This role is ideal for an engineering leader who thrives at the intersection of firmware and hardware, and is excited to take products from early concept to production.

You will be responsible for leading design, development, and verification for firmware and application software systems for our next-generation medical devices.   You will be responsible for driving software architecture, ensuring compliance with IEC 62304, and collaborating cross-functionally with hardware, systems, quality, and regulatory teams.

• Lead the end-to-end development of embedded firmware and supporting application software (e.g., mobile, desktop, or cloud).
• Architect scalable, modular, and testable software systems aligned with medical device standards (IEC 62304, ISO 14971, etc.).
• Define and enforce software development processes, including coding standards, version control, issue tracking, and documentation.
• Own and drive software risk management, traceability, and support for hazard and FMEA analyses.
• Collaborate closely with hardware engineers on board bring-up, driver integration, and system performance tuning.
• Guide or develop verification strategies and lead V&V activities across firmware and software application layers.
• Coordinate with Quality and Regulatory Affairs to prepare documentation for FDA submissions.
• Mentor and technically lead a growing team of software engineers.
• Evaluate and manage outsourced development or test partners as needed.

• B.S. or M.S. in Electrical Engineering, Computer Engineering, or a related field.
• 3 years (Mid-Level) / 8 years (Senior) of hands-on software and/or firmware development experience.
• Proven experience with embedded systems development in C/C (bare-metal or RTOS-based).
• Experience in regulated medical device development (e.g., IEC 62304, ISO 14971, FDA QSR).
• Demonstrated ability to lead design and development of complex systems.
• Familiarity with software development tools: version control (Git), CI/CD, bug tracking, requirements management.
• Strong debugging and system-level troubleshooting skills (e.g., logic analyzers, oscilloscopes, JTAG, logs).

• Experience with Bluetooth/BLE, wireless protocols, or mobile/IoT integration.
• Familiarity with Python scripting for test automation or data analysis.
• Prior experience in startups or fast-paced R&D environments.
• Experience with medical sensor systems, optical sensing, or biophotonics.