Cook Inc - Bloomington
Senior Research and Development Engineer, Systems
Cook Inc - Bloomington, Bloomington, Indiana, United States, 47401
Senior Research and Development Engineer, Systems
Company: Cook Inc. | Location: Bloomington, IN, United States | Position Type: Full Time | Shift Type: 1st Shift | Travel: 20-30% | Category: Engineering
Overview This role is responsible for ensuring the overall functionality, safety, and efficacy of medical devices. Manages the design, development, and integration of firmware, software, hardware, electronics, and disposables.
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.
Qualifications Required Qualifications:
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 Qualifications:
Familiarity with best practices of software development for medical devices
Strong Project Management skills
Familiarity with Agile, GitHub, and Azure Dev Ops
Physical Requirements
Works under general office environmental conditions
Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
Ability to travel 25% of the time
"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."
Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.
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Overview This role is responsible for ensuring the overall functionality, safety, and efficacy of medical devices. Manages the design, development, and integration of firmware, software, hardware, electronics, and disposables.
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.
Qualifications Required Qualifications:
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 Qualifications:
Familiarity with best practices of software development for medical devices
Strong Project Management skills
Familiarity with Agile, GitHub, and Azure Dev Ops
Physical Requirements
Works under general office environmental conditions
Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
Ability to travel 25% of the time
"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."
Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.
#J-18808-Ljbffr