Systems Engineer (medical devices)

SummaryThe Systems Engineer will support the overall technical direction of Acute Therapies products. This role involves contributing across the full product development lifecycle—from feasibility to post-market—focusing on requirements management, risk analysis, system integration, and verification/validation within a regulated medical device environment.Roles & Responsibilities:Support systems engineering activities across all product lifecycle stages (NPD to post-market)Translate clinical and user needs into product requirementsGather and manage requirements from cross-functional inputs (regulatory, quality, manufacturing, service, etc.)Drive system-level design and product realization using engineering best practicesDevelop design concepts and research methodologies aligned with business and user needsCreate and maintain Design History File (DHF) documentationEnsure traceability between requirements, risks, and verification activitiesIdentify technical risks early and implement mitigation strategiesPerform system integration, verification, and validation activitiesConduct root cause analysis using tools like fishbone diagrams, Pareto charts, etc.Assess impact of design/process/material changes and recommend solutionsCollaborate and influence cross-functional teams and stakeholdersEnsure compliance with FDA, ISO, and IEC design control standardsUtilize tools/software to support engineering and documentation activitiesRequired Skills & Qualifications:Strong understanding of systems engineering principlesExperience with electro-mechanical and/or software-integrated systemsKnowledge of requirements management and traceabilityFamiliarity with risk management and reliability engineeringExperience with connected devices / cybersecurity concepts (preferred)Hands-on with tools such as:DOORSTeamcenterTrackWise8JIRA / ALMWorking knowledge of SysML or UMLUnderstanding of statistical methods (DOE, sampling, etc.)Strong analytical, problem-solving, and communication skillsAbility to work independently and manage multiple prioritiesExperience in medical devices, especially ICU or kidney care productsBackground in regulated industries (medical, aerospace, automotive, military)Experience working with global, cross-functional teamsBachelor's or Master's degree in:Electrical EngineeringMechanical EngineeringBiomedical EngineeringSoftware Engineering (or related field)3+ years of relevant experience