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Medical Device System Engineer (Principal Engineer)

 

Job Description

IRRAS Inc. is looking for a talented Software Engineer to maintain, troubleshoot, and revise our proprietary infusion/aspiration system currently indicated to treat hemorrhagic stroke. The candidate will be part of a growing team of engineers demonstrating superb technical competency and delivering lifesaving products worldwide.

The qualified candidate should have a background in computer systems engineering, electrical engineering, or systems engineering and analysis. Ultimately, the role is to build high-quality, innovative and fully-performing software: gathering user requirements, defining system functionality, and writing code in various languages: C and variations of C, Java, and .NET. The candidate shall be intimately familiar with IEC 62304:2006, Medical device software – software life cycle processes.
 

Responsibilities

  • Perform firmware and software upgrades to the IRRAS control unit
  • Ensure the quality of the medical device software meets the design requirements.
  • Ensure design requirements are testable.
  • Develop, implement and maintain test plans, protocols, test scripts and traceability matrix for design verification & validation.
  • Execute protocols/test scripts and document results.
  • Generate and/or update summary reports.
  • Participate in process improvements.
  • Ensure compliance with FDA device regulatory requirements (21 CFR Part 11), including Design History File and 510(k).
  • Using problem tracking software, report issues discovered during testing.
  • Communicate with other project team members to ensure schedules and requirements are consistent with project expectations.
  • Maintain design verification and validation documentation in accordance with established departmental and corporate procedures.
  • Participate in review and update of SOPs in the spirit of continuous improvement.
  • Possess excellent verbal and written communication skills.

 

Requirements

  • BS/MS degree in Computer Science, Engineering or a related subject
  • 7-10 years in the medical device developing industry and medical device coding
  • A comprehensive understanding of IEC 62304:2006
  • Experience with test-driven development
  • Experience with hospital monitoring systems a plus
  • Experience with automation software (e.g., Puppet, cfengine, Chef)
  • Scripting skills (e.g., shell scripts, Perl, Ruby, Python)
  • Networking knowledge (OSI network layers, TCP/IP)
  • Experience with PIC micro-processors a plus
  • Ability to develop software in Java, C++ or other programming languages
  • Ability to document requirements and specifications
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