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Senior Research and Development Engineer, Systems

Cook Medical

Cook Medical

Bloomington, IN, USA
Posted on Oct 23, 2025

Senior Research and Development Engineer, Systems

Requisition ID 2025-17502
Posting Date 17 hours ago(10/22/2025 3:09 PM)
Job Location(s)
Bloomington IN United States
Job Locations
US-IN-Bloomington
Travel
20-30%
Shift Type
1st shift
Position Type
Full Time
Company
Cook Inc - Bloomington
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

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“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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