Principal Firmware Engineer - Implantable Medical Devices

Location: St. Louis Park, MN

• Design, develop, and test firmware for active implantable medical devices, ensuring high reliability and performance under strict power and size constraints.
• Collaborate with cross-functional teams, including hardware engineers, software developers, and regulatory specialists, to integrate firmware with device hardware and external systems.
• Implement and validate communication protocols (e.g., Bluetooth Low Energy, proprietary RF) for secure data transmission between active implantable devices and external interfaces.
• Ensure compliance with medical device standards, such as ISO 13485, IEC 62304, and FDA regulations, throughout the development lifecycle.
• Optimize firmware for low-power operation to extend the lifespan of active implantable devices.
• Conduct risk analysis, debugging, and verification to ensure firmware meets safety and efficacy requirements.
• Document all development processes, including design specifications, test plans, and validation reports, in accordance with regulatory requirements.
• Support clinical trials and post-market surveillance by analyzing device performance and implementing firmware updates as needed.

• Education: Bachelor’s or master’s degree in electrical engineering, Computer Engineering, Computer Science, or a related field.
• Experience:
  • 7+ years of experience developing firmware for embedded systems, with at least 5 years focused on active implantable medical devices required.
  • Proven expertise in programming in C/C++ for resource-constrained environments required.
  • Experience with real-time operating systems (RTOS) and bare-metal programming.
  • Familiarity with medical device regulations (e.g., FDA, ISO 13485, IEC 62304).
  • Hands-on experience with low-power wireless communication protocols (e.g., BLE, Zigbee).
  • Experience using software development tools such as GitHub and Jira.
  • Experience conducting static analysis and unit testing using tools such as PC-Lint and GTest.
• Skills:
  • Strong understanding of embedded systems architecture and hardware-software integration required.
  • Proficiency in debugging tools (e.g., JTAG, oscilloscopes, logic analyzers).
  • Knowledge of cybersecurity principles for medical devices, including encryption and secure data transfer.
  • Ability to work in a highly regulated environment with a focus on safety and quality.
  • Excellent problem-solving skills and attention to detail.
  • Demonstrated ability to translate business needs into clear technical requirements.
  • Proven ability to mentor and lead a team of engineers in implementing those technical requirements
• Preferred:
  • Knowledge of battery management systems for implantable devices.
  • Familiarity with Agile development methodologies.