Medical Device Software Engineer Jobs in Minneapolis, MN

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency, and respiratory illnesses. The Principal Embedded Software Engineer provides technical leadership for the firmware and embedded software used in regulated medical devices. This role is responsible for guiding embedded software architecture, supporting development across bare-metal and RTOS-based platforms, and helping establish future embedded Linux and connected device capabilities while ensuring software is developed with the rigor required for regulated medical device development.

• Lead the design, development, debugging, integration, and maintenance of embedded software for Class II regulated medical device products.
• Define and evolve embedded software architecture, module boundaries, interfaces, design patterns, and technical standards that support reliability, maintainability, testability, cybersecurity, and long-term product support.
• Provide technical leadership for connected device capabilities, including Wi-Fi and Bluetooth connectivity, mobile/cloud integration, provisioning, diagnostics, telemetry, secure updates, and data exchange across firmware, mobile, and cloud systems.
• Develop embedded software in C/C++ for microcontroller, RTOS, bare-metal, and resource-constrained environments while helping evaluate and establish future embedded Linux platform capabilities.
• Create clear software architecture, design specification, interface definition, traceability, verification, cybersecurity, and release documentation that supports regulated product development and submission readiness.
• Contribute to platform-level decisions involving bootloaders, device drivers, board support packages, middleware, communication stacks, diagnostics, software update mechanisms, and device application behavior.
• Provide technical guidance and mentorship through design reviews, code reviews, implementation planning, troubleshooting, and technical trade-off decisions.
• Improve embedded software engineering practices related to source control, peer review, static analysis, unit testing, automated builds, CI/CD, release readiness, defect prevention, and post-release support.

• Bachelor's degree in Computer Engineering, Computer Science, or a related technical discipline.
• 10+ years developing embedded firmware, embedded software, or device software for commercial products.
• Senior technical leadership background, including leading embedded software design decisions, mentoring engineers, setting technical direction, or serving as a technical lead for complex product development efforts.
• Strong proficiency in C/C++ development for microcontrollers, RTOS, bare-metal systems, or resource-constrained embedded environments.
• Depth in embedded software architecture, module design, interface definition, state machines, communication protocols, diagnostics, embedded debugging, and hardware/software integration.
• Regulated product development background, with knowledge of medical device software lifecycle expectations such as IEC 62304, design controls, requirements traceability, software verification, risk management, and design history file documentation.
• Clear written and verbal communication skills, with the ability to explain complex technical issues, risks, and trade-offs to technical and non-technical stakeholders.

• Class II medical device software development, preferably for products cleared through the FDA 510(k) pathway.
• Embedded Linux background, including board support packages, kernel configuration, device drivers, bootloaders, root file systems, Yocto, Buildroot, or similar platform technologies.
• FDA 510(k) software documentation contributions, including software architecture, software design specifications, requirements, traceability, verification evidence, cybersecurity documentation, and release documentation.
• Secure embedded software development practices such as secure boot, signed updates, vulnerability management, SBOM/SOUP concepts, and medical device cybersecurity guidance.
• Connected device architecture, device provisioning, diagnostics, telemetry, over-the-air updates, mobile/cloud integration, or edge-to-cloud workflows.