Principal Firmware Engineer - Implantable Medical Devices

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., * 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.

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.