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• G

  Principal Firmware Engineer  

  Gateway Recruiting

  full_time - Minneapolis

  Posted: 20/01/2026

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  Job DescriptionJob DescriptionPosition OverviewWe are seeking a skille... Read More

  Job DescriptionJob Description

  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.

  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.

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• G

  Senior Software Engineer  

  Gateway Recruiting

  full_time - Minneapolis

  Posted: 20/01/2026

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  Job DescriptionJob DescriptionJob Summary:This role is seeking a Senio... Read More

  Job DescriptionJob Description

  Job Summary:
  This role is seeking a Senior Software Engineer with specialized experience in developing software for active implantable medical device systems. This role involves creating robust, secure, and scalable programming software and mobile applications that interface with implantable devices. The ideal candidate will have experience in medical device development, system integration, and regulatory compliance, with a passion for building technology that improves patient outcomes.
  
  Responsibilities:

  Design, develop, and maintain programmer software for medical device systems, including embedded components and mobile apps (iOS/Android).Build secure and user-friendly mobile applications for clinicians and patients to monitor and interact with implantable devices.Collaborate with cross-functional teams—hardware engineers, firmware developers, and clinical specialists—to ensure seamless integration between device, software, and external systems.Implement secure communication protocols (e.g., Bluetooth Low Energy, proprietary RF) for data exchange between implantable devices and mobile apps.Ensure adherence to medical device standards such as ISO 13485, IEC 62304, and FDA regulations throughout the software lifecycle.Optimize software for performance, reliability, and cybersecurity in a highly regulated environment.Conduct risk analysis, debugging, and verification to ensure software meets safety and efficacy requirements. Document design specifications, test plans, and validation reports per regulatory requirements.Support clinical trials and post-market activities by analyzing system performance and deploying software updates.Apply AI-based techniques for code development and process improvement, including automated code generation and intelligent code review.

  Required Qualifications:

  Bachelor's or Master's degree in Computer Science or Computer Engineering, or a related field.5+ years of experience developing software for medical devices or regulated systems.Strong proficiency in programming languages such as C/C++, C#, Python, Java, or Swift/Kotlin for mobile development. Experience with embedded systems and real-time operating systems (RTOS) as well as application-level development. Familiarity with medical device regulations (FDA, ISO 13485, IEC 62304). Hands-on experience with wireless communication protocols (BLE) and secure data transfer. Experience with software development tools (GitHub, Jira) and automated testing frameworks.

  Preferred Qualifications:

  Experience with mobile app development for healthcare applications.Familiarity with Agile development methodologies.Knowledge of battery management systems and low-power optimization for connected devices.

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