At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.

At Tactile Medical, we are committed to helping patients with chronic conditions live better through innovative, clinically supported at-home therapies. As a Senior Firmware Engineer, you will play a key role in the development and support of embedded software for regulated medical devices. This position is responsible for designing, developing, integrating, and maintaining firmware solutions that are reliable, scalable, and release-ready.

Working closely with cross-functional teams, you will contribute to product architecture, support system integration and troubleshooting efforts, and help advance engineering best practices. The ideal candidate brings deep embedded software expertise, experience developing software for regulated medical devices, and a passion for mentoring others while driving high-quality technical outcomes.

Responsibilities

• Design, develop, integrate, test, and maintain embedded firmware for regulated medical device products.
• Lead development of complex firmware features and subsystems from concept through implementation, verification, release, and post-market support.
• Develop robust and maintainable software using C/C++ for microcontroller-based, RTOS, bare-metal, and resource-constrained embedded systems.
• Support hardware and software integration activities, including board bring-up, peripheral validation, diagnostics, and system-level troubleshooting.
• Develop and support connectivity solutions, including Wi-Fi, Bluetooth, cloud-connected, and mobile-integrated device features.
• Create and maintain software lifecycle deliverables, including requirements, design documentation, traceability artifacts, verification support documentation, and release documentation.
• Apply software development processes aligned with medical device regulations and standards, including IEC 62304, ISO 14971, software risk management, design controls, and change impact assessments.
• Participate in architecture discussions, technical reviews, and engineering decision-making to support long-term product quality and maintainability.
• Conduct design and code reviews and provide technical leadership, mentorship, and guidance to engineering team members.
• Collaborate effectively with internal stakeholders, external partners, and offshore development resources to deliver high-quality solutions.

Required Qualifications

• Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, or a related technical discipline.
• 7+ years of experience developing firmware, embedded software, or device software for commercial products.
• Strong proficiency in C/C++ development for microcontroller-based, RTOS, bare-metal, or resource-constrained embedded systems.
• Experience developing software for regulated medical devices, including Class II medical devices and/or products cleared through the FDA 510(k) process.
• Working knowledge of IEC 62304, ISO 14971, software verification, requirements traceability, design controls, and regulated software development documentation.
• Experience troubleshooting complex embedded systems and supporting hardware/software integration activities.
• Strong problem-solving, communication, and collaboration skills.

Preferred Qualifications

• Experience developing firmware for connected medical devices, including diagnostics, telemetry, provisioning, secure updates, manufacturing test, service tools, and post-market support.
• Familiarity with secure embedded software development practices, including secure boot, signed firmware updates, software bill of materials (SBOM), SOUP management, vulnerability management, and medical device cybersecurity guidance.
• Experience with wired and wireless communication technologies, including BLE, Wi-Fi, cellular, USB, UART, SPI, I2C, CAN, Ethernet, MQTT, and related protocols.
• Experience supporting FDA 510(k) software documentation, including software requirements, design specifications, traceability matrices, verification evidence, cybersecurity documentation, and release documentation.
• Demonstrated success improving firmware engineering practices through peer reviews, coding standards, static analysis, automated builds, testability, defect prevention, and release readiness initiatives.

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