Systems Engineer

Sr Systems EngineerLocation: Minneapolis, Minnesota 55432 Contract: 12+ MonthsSkillsets: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 releaseExperience with designing for the Hardware/Firmware/communication interfaces of electronic devicesExperience in troubleshooting firmware/software interfacesProduct 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 systemsDemonstrated strong verbal/written communicationDemonstrated ability to make decisions quickly and guide a team through complex problemsExperience working in cross-functional and team environments