Principal Firmware Engineer

CVRx, Inc.-posted 3 days ago
Full-time • Principal
Brooklyn Park, MN
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CVRx is seeking a highly-skilled Firmware Engineer who has experience in architecting and developing firmware for active, implantable medical device systems or equivalent technologies. This role will primarily support and enhance an established firmware architecture. Our successful candidate will embrace the existing system, deeply understand its implementation, help technical teams and leaders understand and support the implementation, and drive continuous improvement through cross-functional collaboration. The Principal Firmware Engineer will lead efforts to maintain, improve, and adapt our existing firmware to meet future product needs, ensuring continuity and stability. If new functionality is required that cannot or should not be supported by the current architecture, the engineer will evaluate and propose a new firmware architecture after thorough consideration of the limitations and opportunities with the existing system.

  • Support and maintain the existing firmware architecture, ensuring reliability and compliance with medical device standards.
  • Develop a deep understanding of the current firmware implementation and proactively share knowledge with technical teams and stakeholders.
  • Educate and mentor others on the design, operation, and rationale behind the existing system.
  • Lead and recommend improvements and enhancements that build upon the current architecture, prioritizing maintainability and adaptability for future product requirements.
  • Represent a philosophy of continuous improvement—modifying and evolving the firmware as needed, while respecting and leveraging the strengths of the established system and managing risk throughout the process.
  • Collaborate with internal and contract cross-functional teams to ensure proposed changes enhance workflow and methodologies and align with organizational goals and regulatory requirements.
  • May direct personnel and firmware related project activities in collaboration with external contract firmware and system experts.
  • Define requirements and specifications, architect firmware systems for Class III implantable products and programming systems, and document firmware system requirements through documents, reports, memos, and change requests.
  • Responsible for analyzing, designing, programming, debugging, and modifying real-time applications, often involving analog and digital hardware as well as software operating systems, which require knowledge and exposure to hardware design.
  • Develop and maintain automated CI/CD platforms for firmware development iteration, design verification and production testing, maximizing availability, improving test coverage and ensuring rapid, reliable completion.
  • Integrate automated build, static code analysis, and test frameworks into the CI/CD process to enforce code quality, regulatory compliance, and early defect detection.
  • Lead risk management activities, including reliability analysis and hazard assessment, to ensure compliance with medical device standards and regulations.
  • Implement root cause analysis and corrective actions for firmware and hardware issues.
  • Lead the design and implementation of security features and controls in firmware, including encryption, to ensure compliance with internal SOPs, regulatory standards, and industry best practices.
  • Lead the design and implementation of firmware design verification tests.
  • Integrate Secure Software Development Life Cycle (SSDLC) practices into firmware development, embedding security requirements from initial design through deployment and maintenance.
  • Collaborate with IT and security teams to monitor, assess, and respond to cybersecurity risks, including supply chain vulnerabilities and incident response.
  • Participate in research and integration of new functions and features into the existing systems.
  • Participate in the research and development of new technologies and products as required.
  • Other duties as assigned by manager
  • B.S. in Computer Engineering, Electrical Engineering, Computer Science, or Software Engineering.
  • 10 or more years experience in a regulated industry (medical device manufacturing, aerospace, etc.)
  • Experience with the following technologies; C, C++, C#, RTOS, OOP, JTAG, MICS, OTS ULP micro-controllers
  • Familiarity with FDA regulations and guidance docs, and external standards, including EN 62304, ISO 14971, and AAMI TIR57 or similar regulated industry experience
  • Valid identification approved for international flight and travel
  • Valid driver’s license in good standing and reliable personal transportation
  • M.S. in Computer Engineering, Electrical Engineering, Computer Science, or Software Engineering.
  • Experience/knowledge associated with the processes associated with an implantable medical device system.
  • Product design experience from concept to manufacturing in a regulated device product development environment.
  • Competitive Health & Dental Insurance options with generous Company contributions
  • Company contributions to an HSA with a high-deductible insurance plan selection
  • 401(k) with a company match
  • Employee stock purchase plan (ESPP) & stock option grants
  • 12 company-paid holidays per year in addition to a generous Flex PTO plan
  • Generous paid time off for new parents
  • Company-paid life insurance & disability options
  • Unlimited growth opportunities in a growing company
  • Endless training & learning opportunities
  • Flexible Schedule
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