Principal Systems Evaluation Engineer

Analyze system requirements and user needs for testability, perform system interaction analysis, and coordinate system evaluation activities (i.e. validation, verification, DAT) based on system requirements, user needs and system design. Perform design analysis and exploratory testing. Work with electrical and mechanical hardware and associated tools and infrastructure. Develop and maintain high quality non-medical device software tools in a regulated environment to support system design and system evaluation functions. Provide leadership and continuously improve System V&V processes and work methodologies (using agile/lean principles to eliminate waste) by solving complex problems and interfacing with peers/cross-functional groups and analyze activities to improve workflow. Establish and promote a work environment that supports the Quality Policy and Quality System. Participate in and support pre-clinical studies. Bachelor's degree in electrical engineering, Computer Engineering, Computer Science or related field 10+ years of overall work experience with 8+ years in engineering with product development, including experience with automated and manual testing. Experience with requirements analysis, design, trade-off analysis, systems integration, risk management and V&V processes. Ability to interpret and research system requirements, system specifications, input/output processes. Proficient with Python and working knowledge of C++ or Java. Experience with configuration management, test management, requirements management, and issue tracking systems such as JIRA, AccuRev, Windchill etc. Willingness to work onsite at our Arden Hills location. Experience in software/hardware engineering. Experience automated and manual testing in regulated industry, preferably in cardiac medical device domain. Experience supporting global teams. Experience in system development lifecycle process including formalized processes and procedures. Experience tracking System Verification & Validation (V&V) efforts by creating and maintaining records using approved tracking management tools. Ability to interpret and apply regulations and standards relevant to class II/III medical devices required. Experience collecting, organizing, synthesizing, and analyzing data; summarizing findings, and developing conclusions and recommendations from all stakeholders using all sources of data.