Principal Firmware Engineer - Implantable Medical Devices

Enterra Medical is seeking a skilled Principal Firmware Engineer with experience in developing firmware for active implantable medical devices. The ideal candidate will have a strong background in embedded systems, real-time operating systems, and regulatory compliance for medical devices.

Requirements

• 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 to integrate firmware with device hardware and external systems.
• 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

• Generous Paid Time Off
• 401k Matching
• Retirement Plan