{"schemaVersion":"jobsearcher.job.v1","id":"09e22f253f2f199045560021","url":"https://jobsearcher.com/jobs/09e22f253f2f199045560021","canonicalUrl":"https://jobsearcher.com/jobs/09e22f253f2f199045560021","title":"Senior Systems Engineer","description":"Roles & Responsibilities:\n\nPerform 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 surveillance\n\nUnderstand clinical and user needs and apply them to product realization\n\nCapture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc.\n\nUse knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective\n\nCraft design concepts and research methodologies that best meet current and future customer / business needs for a product or process domain area\n\nCreate and maintain design history file elements\n\nFacilitate an improved understanding of the interrelationship between requirements, risk and reliability\n\nAnticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal results\n\nResolve systems-related technical issues by applying problem-solving tools such as cause-and-effect diagrams, Pareto charts, etc.\n\nPropose and drive solutions to technical problems that are ambiguous and diverse in scope\n\nPerform 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 rationale.\n\nInfluence stakeholders and cross-functional team members within the project\n\nDrive adherence to FDA, ISO and IEC design control procedures, regulations and standards\n\nUse various software tools and programs to complete the above responsibilities\n\nEducation and Experience:\n\nBachelor's degree or Master's degree and three years or more of relevant experience, with a degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline\n\nPrior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains\n\nSound knowledge of systems engineering and related areas such as electro-mechanical and software engineering\n\nA track record in electro-mechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or military\n\nPrior experience with internet-connected, software-enabled devices and/or cyber security\n\nWorking knowledge of system modeling language (SysML or UML) and requirement management tools\n\nKnowledge of DOORS and Jama requirements management tools preferred\n\nKnowledge of Teamcenter, TrackWise8, JIRA, and ALM preferred\n\nFamiliar with statistical methods/tools for design and verification, e.g. DOE, sample size\n\nSuccess in working with multi-functional, global teams\n\nExcellent interpersonal, communication, and influencing skills\n\nAbility to work independently\n\nAbility to manage simultaneously several projects and shift priority according to needs\n\nDemonstrated strong analytical and problem-solving skills\n\nAbility to solve problems, develop solutions, and make recommendations in collaboration with project leaders\n\nCreative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks\n\nAbility to deliver results according to the plan\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Minneapolis","state":"MN","isRemote":false,"isActive":false,"createdAt":"2026-09-03T04:19:05.319Z","occupations":[{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Systems Engineer","description":"Roles & Responsibilities:\n\nPerform 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 surveillance\n\nUnderstand clinical and user needs and apply them to product realization\n\nCapture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc.\n\nUse knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective\n\nCraft design concepts and research methodologies that best meet current and future customer / business needs for a product or process domain area\n\nCreate and maintain design history file elements\n\nFacilitate an improved understanding of the interrelationship between requirements, risk and reliability\n\nAnticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal results\n\nResolve systems-related technical issues by applying problem-solving tools such as cause-and-effect diagrams, Pareto charts, etc.\n\nPropose and drive solutions to technical problems that are ambiguous and diverse in scope\n\nPerform 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 rationale.\n\nInfluence stakeholders and cross-functional team members within the project\n\nDrive adherence to FDA, ISO and IEC design control procedures, regulations and standards\n\nUse various software tools and programs to complete the above responsibilities\n\nEducation and Experience:\n\nBachelor's degree or Master's degree and three years or more of relevant experience, with a degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline\n\nPrior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains\n\nSound knowledge of systems engineering and related areas such as electro-mechanical and software engineering\n\nA track record in electro-mechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or military\n\nPrior experience with internet-connected, software-enabled devices and/or cyber security\n\nWorking knowledge of system modeling language (SysML or UML) and requirement management tools\n\nKnowledge of DOORS and Jama requirements management tools preferred\n\nKnowledge of Teamcenter, TrackWise8, JIRA, and ALM preferred\n\nFamiliar with statistical methods/tools for design and verification, e.g. DOE, sample size\n\nSuccess in working with multi-functional, global teams\n\nExcellent interpersonal, communication, and influencing skills\n\nAbility to work independently\n\nAbility to manage simultaneously several projects and shift priority according to needs\n\nDemonstrated strong analytical and problem-solving skills\n\nAbility to solve problems, develop solutions, and make recommendations in collaboration with project leaders\n\nCreative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks\n\nAbility to deliver results according to the plan\n\n#J-18808-Ljbffr","datePosted":"2026-09-03T04:19:05.319Z","dateModified":"2026-09-03T04:19:05.319Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Minneapolis","addressRegion":"MN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"09e22f253f2f199045560021"},"url":"https://jobsearcher.com/jobs/09e22f253f2f199045560021"}}