Principal Firmware Engineer - Implantable Medical Devices

Enterra Medical, Inc. • Saint Louis Park, MN

83d • $130,000 - $160,000

About The Position

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.

Requirements

• Bachelor’s or master’s degree in electrical engineering, Computer Engineering, Computer Science, or a related field.
• 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.

Nice To Haves

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

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.

Benefits

• Salary: $130,000-160,000 DOE

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 11-50 employees