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, anduser 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
Requisition ID2025-17502
Posting Date4 months ago(10/22/2025 3:09 PM)
Job Location(s)Bloomington IN United States
Job LocationsUS-IN-Bloomington
Travel20-30%
Shift Type1st shift
Position TypeFull Time
CompanyCook Inc - Bloomington
CategoryEngineering
Senior Research and Development Engineer, Systems • Bloomington, IN, United States
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