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 OverviewWe 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 ResponsibilitiesDesign, develop, and test firmware for active implantable medical devices, ensuring high reliability and performance under strict power and size constraintsCollaborate with cross-functional teams, including hardware engineers, software developers, and regulatory specialists, to integrate firmware with device hardware and external systemsImplement and validate communication protocols (e.g., Bluetooth Low Energy, proprietary RF) for secure data transmission between active implantable devices and external interfacesEnsure compliance with medical device standards, such as ISO 13485, IEC 62304, and FDA regulations, throughout the development lifecycleOptimize firmware for low-power operation to extend the lifespan of active implantable devicesConduct risk analysis, debugging, and verification to ensure firmware meets safety and efficacy requirementsDocument all development processes, including design specifications, test plans, and validation reports, in accordance with regulatory requirementsSupport clinical trials and post-market surveillance by analyzing device performance and implementing firmware updates as neededQualificationsEducation: Bachelor’s or master’s degree in electrical engineering, Computer Engineering, Computer Science, or a related fieldExperience:7+ years of experience developing firmware for embedded systems, with at least 5 years focused on active implantable medical devices requiredProven expertise in programming in C/C++ for resource-constrained environments requiredExperience with real-time operating systems (RTOS) and bare-metal programmingFamiliarity 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 JiraExperience conducting static analysis and unit testing using tools such as PC-Lint and GTestSkills:Strong understanding of embedded systems architecture and hardware-software integration requiredProficiency in debugging tools (e.g., JTAG, oscilloscopes, logic analyzers)Knowledge of cybersecurity principles for medical devices, including encryption and secure data transferAbility to work in a highly regulated environment with a focus on safety and qualityExcellent problem-solving skills and attention to detailPreferred:Knowledge of battery management systems for implantable devicesFamiliarity with Agile development methodologiesSalary: $130,000-160,000 DOEPowered by JazzHRp9Y0SaezN9