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Principal Firmware Engineer - Implantable Medical Devices

Principal Firmware Engineer - Implantable Medical Devices

Enterra Medical, Inc.St. Louis Park, MN, US
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Location :

  • Minneapolis, MN Hybrid (In office weekly as needed) Company Summary : Enterra Medical is a medical device company dedicated to a singular focus : helping more people with chronic gastroparesis live better lives by advancing technology, expanding clinical science, and accelerating access to the Enterra® Therapy.
  • Position Overview We are seeking a skilled Principal Firmware Engineer with specialized experience in developing firmware for active implantable medical devices.
  • This role involves designing, developing, testing, and optimizing embedded software to ensure the safety, reliability, and performance of cutting-edge medical technologies.
  • The ideal candidate will have a strong background in embedded systems, real-time operating systems, and regulatory compliance for medical devices.
  • Key Responsibilities 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.

Qualifications 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.
  • Preferred :

  • Knowledge of battery management systems for implantable devices.
  • Familiarity with Agile development methodologies.
  • Salary :

  • $130,000-160,000 DOE   Powered by JazzHR
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    Principal Firmware Engineer • St. Louis Park, MN, US