Medical Device System Engineer (Principal Engineer)
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.
- 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.
- 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