Senior Systems Engineering

Senior Systems EngineerOur Fortune 500 client (One of the world's largest Healthcare companies) in North Plymouth MN is looking for hardworking, motivated talent to join their innovative team.Role DescriptionIn the Systems Engineer role, you will be supporting the overall technical direction of Acute Therapies products. Tasks may include product requirements management, traceability, DHF structure & maintenance, product risk management, system integration, verification, and validation of medical devices.What You'll Be DoingPerform the activities associated with the systems engineering of one or more products in various stages of the product lifecycle from new product development to post-market surveillanceUnderstand clinical and user needs and apply them to product realizationCapture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc.Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspectiveCraft design concepts and research methodologies that best meet current and future customer / business needs for a product or process domain areaCreate and maintain design history file elementsFacilitate an improved understanding of the interrelationship between requirements, risk and reliabilityAnticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal resultsResolve systems-related technical issues by applying problem-solving tools such as cause-and-effect diagrams, Pareto charts, etc.Propose and drive solutions to technical problems that are ambiguous and diverse in scopePerform impact assessments on the requirements on an ongoing basis for any proposed design / material / process changes or observations from field / service / manufacturing. As needed, propose recommended mitigations with rationaleInfluence stakeholders and cross-functional team members within the projectDrive adherence to FDA, ISO and IEC design control procedures, regulations and standardsUse various software tools and programs to complete the above responsibilitiesWhat You'll BringPrior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domainsSound knowledge of systems engineering and related areas such as electro-mechanical and software engineeringA track record in electro-mechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or militaryPrior experience with internet-connected, software-enabled devices and/or cyber securityWorking knowledge of system modeling language (SysML or UML) and requirement management toolsKnowledge of DOORS, Teamcenter, TrackWise8, JIRA, and ALM preferredFamiliar with statistical methods/tools for design and verification, e.g. DOE, sample sizeSuccess in working with multi-functional, global teamsExcellent interpersonal, communication, and influencing skillsAbility to work independentlyAbility to manage simultaneously several projects and shift priority according to needsDemonstrated strong analytical and problem-solving skillsAbility to solve problems, develop solutions, and make recommendations in collaboration with project leadersCreative Problem Solver - identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocksAbility to deliver results according to the planBachelors or Masters degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline.