• Senior Research and Development Engineer, Systems

    Cook Medical (Bloomington, IN)


    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 Date6 days 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