Principal Firmware Engineer jobs in United States
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CVRx | Barostim · 1 month ago

Principal Firmware Engineer

CVRx, Inc. is seeking a highly-skilled Principal Firmware Engineer to support and enhance their established firmware architecture for active, implantable medical device systems. The role involves maintaining the firmware, leading improvements, collaborating with cross-functional teams, and ensuring compliance with medical device standards.

BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

CC++RTOSFirmware architectureOOPJTAGMICSFDA regulationsISO 14971AAMI TIR57Automated CI/CDSecurity featuresRoot cause analysisContinuous improvementRisk managementMentoringCollaboration

Required

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

Preferred

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

Benefits

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

Company

CVRx | Barostim

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CVRx is a commercial stage, public (NASDAQ: CVRX) medical devices company located in Minneapolis, Minnesota.

H1B Sponsorship

CVRx | Barostim has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)

Funding

Current Stage
Public Company
Total Funding
$390.6M
Key Investors
Johnson & Johnson Development CorporationOxford Finance LLCYsios Capital
2021-06-29IPO
2020-07-07Private Equity· $50M
2019-08-09Series G· $93M

Leadership Team

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Robert John
Chief Revenue Officer (CRO)
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Company data provided by crunchbase