Cook Medical ยท 1 week ago
Senior Research and Development Engineer, Systems
Bloomington, IN
Full-time
Onsite
Senior Level
5+ years expCook Medical is a company focused on the development of medical devices. The Senior Research and Development Engineer, Systems role is responsible for ensuring the functionality, safety, and efficacy of these devices by managing the design, development, and integration of various engineering disciplines.
HardwareManufacturingMedical Device
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
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
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.
10001+ employees
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 StageLeadership Team
G
Gayle Cook
Co-founder
Kelly Fischer
Senior Vice President and Chief Financial Officer
Recent News
Company data provided by crunchbase