Senior Research and Development Engineer, Systems jobs in United States
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Cook Medical ยท 5 hours ago

Senior Research and Development Engineer, Systems

Cook Medical is a company focused on medical devices, and they are seeking a Senior Research and Development Engineer to ensure the functionality, safety, and efficacy of their products. The role involves managing the design and development of firmware, software, hardware, and electronics, while also leading systems integration efforts and ensuring compliance with industry standards.

HardwareManufacturingMedical Device
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H1B Sponsor Likelynote

Responsibilities

Develop system architectures and specifications including: defining user requirements, design inputs, software requirements, feature descriptions, and user stories
Conduct risk management activities including risk analysis for system, software, and cybersecurity
Lead systems integration efforts across various engineering disciplines
Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971
Ability to effectively work and communicate in technical cross-functional teams to develop new products
Continuously improves process and work methodologies by interfacing with peers/crossfunctional groups and analyzing activities to improve work processes

Qualification

Biomedical EngineeringSoftware IntegrationIEC Standards KnowledgeAgile DevelopmentProject ManagementBlack Box TestingDesign ControlsSDLCGitHubAzure Dev Ops

Required

BS Degree in Biomedical/Electrical, Systems/Software Engineering, or related field; Masters preferred
Minimum of 5 years of experience analyzing system requirements, design, and testing
Software integration, and black box testing methodologies
Experience with multi-tasking real-time operating system
Agile development experience
Strong working knowledge of IEC 60601, IEC 62304, ISO 13485, and ISO 14971
Experience and understanding of Design Controls and SDLC

Preferred

Familiarity with best practices of software development for medical devices
Strong Project Management skills
Familiarity with Agile, GitHub, and Azure Dev Ops

Company

Cook Medical

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Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group.

H1B Sponsorship

Cook Medical 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
2025 (3)
2023 (3)
2022 (2)

Funding

Current Stage
Late Stage

Leadership Team

G
Gayle Cook
Co-founder
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Kelly Fischer
Senior Vice President and Chief Financial Officer
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Company data provided by crunchbase