Senior Research and Development Engineer, Systems

Bloomington, IN, US • Posted 1 day ago • Updated 12 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Research and Development
  • Firmware
  • Computer Hardware
  • Electronics
  • User Stories
  • Risk Management
  • Risk Analysis
  • Cyber Security
  • Regulatory Compliance
  • Biomedicine
  • Electrical Systems
  • Software Engineering
  • System Requirements
  • Testing
  • System Integration
  • Black-box Testing
  • Multitasking
  • Real-time
  • Operating Systems
  • ISO 13485
  • ISO 9000
  • Design Controls
  • Software Development Methodology
  • Software Development
  • Medical Devices
  • Project Management
  • Agile
  • GitHub
  • Microsoft Azure

Summary

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 2-5 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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 80183843
  • Position Id: 4e86554036231cfb8fdcdd4fc003fcdd
  • Posted 1 day ago
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