Principal Firmware Engineer - Implantable 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.

Pay

$130,000-160,000 DOE