Principal Firmware Engineer - Implantable Medical Devices

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.

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