Sr Systems Engineer
Infotree Global Solutions
Sr Systems Engineer :: Minneapolis Minnesota 55432
Contract :: 12+ Months Skillsets:
Contract :: 12+ Months Skillsets:
- Experience developing system definition, system design and requirements, requirement tracing to subsystems and interface requirements, and system verification and validation strategy and testing.
- Previous medical device experience with a history of developing products from technology to market release
- Experience with designing for the Hardware/Firmware/communication interfaces of electronic devices
- Experience in troubleshooting firmware/software interfaces
- Product Risk Assessment and Risk Management Experience (Fault Tree Analysis, Failure Modes, and Effects Analysis, etc.)
- Experience working with and designing systems to meet ISO and Quality System Regulation requirements, including IEC-60601-1, -2, -6, IEC-62304, ISO-14971, FDA 21CFR820.30 for Class I, II and III medical systems
- Demonstrated strong verbal/written communication
- Demonstrated ability to make decisions quickly and guide a team through complex problems
- Experience working in cross-functional and team environments
- Experience working in FDA regulated and/or medical device environment
Vacancy posted 3 days ago
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