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AI Jobs in Plymouth, MN

Systems Engineer (medical devices)

Katalyst Healthcares & Life Sciences
  • Plymouth, MN
  • Quick Apply
30+ days ago

Job Description

Summary
  • The 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 requirements
  • Gather and manage requirements from cross-functional inputs (regulatory, quality, manufacturing, service, etc.)
  • Drive system-level design and product realization using engineering best practices
  • Develop design concepts and research methodologies aligned with business and user needs
  • Create and maintain Design History File (DHF) documentation
  • Ensure traceability between requirements, risks, and verification activities
  • Identify technical risks early and implement mitigation strategies
  • Perform system integration, verification, and validation activities
  • Conduct root cause analysis using tools like fishbone diagrams, Pareto charts, etc.
  • Assess impact of design/process/material changes and recommend solutions
  • Collaborate and influence cross-functional teams and stakeholders
  • Ensure compliance with FDA, ISO, and IEC design control standards
  • Utilize tools/software to support engineering and documentation activities

Required Skills & Qualifications:
  • Strong understanding of systems engineering principles
  • Experience with electro-mechanical and/or software-integrated systems
  • Knowledge of requirements management and traceability
  • Familiarity with risk management and reliability engineering
  • Experience with connected devices / cybersecurity concepts (preferred)
  • Hands-on with tools such as:
  • DOORS
  • Teamcenter
  • TrackWise8
  • JIRA / ALM
  • Working knowledge of SysML or UML
  • Understanding of statistical methods (DOE, sampling, etc.)
  • Strong analytical, problem-solving, and communication skills
  • Ability to work independently and manage multiple priorities
  • Experience in medical devices, especially ICU or kidney care products
  • Background in regulated industries (medical, aerospace, automotive, military)
  • Experience working with global, cross-functional teams
  • Bachelor's or Master's degree in:
  • Electrical Engineering
  • Mechanical Engineering
  • Biomedical Engineering
  • Software Engineering (or related field)
  • 3+ years of relevant experience

Numbers & Facts

LocationPlymouth, MN

Skills

  • Aerospace and Defenseunmatched
  • Analysis Skillsunmatched
  • Atlassian JIRAunmatched
  • Best Practicesunmatched
  • Biomedical Engineeringunmatched
  • Communication Skillsunmatched
  • Cross-Functionalunmatched
  • Documentationunmatched
  • Electrical Engineeringunmatched
  • Electromechanicsunmatched
  • FDA (Food and Drug Administration)unmatched
  • File Maintenanceunmatched
  • ISO (International Organization for Standardization)unmatched
  • Intensive Careunmatched
  • International Electro-Technical Commission (IEC)unmatched
  • Internet Securityunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Mechanical Engineeringunmatched
  • Medical Equipmentunmatched
  • Militaryunmatched
  • Multitaskingunmatched
  • Problem Solving Skillsunmatched
  • Product Designunmatched
  • Product Developmentunmatched
  • Product Engineeringunmatched
  • Product Lifecycleunmatched
  • Product Managementunmatched
  • Regulationsunmatched
  • Reliability Engineeringunmatched
  • Requirements Managementunmatched
  • Risk Analysisunmatched
  • Risk Managementunmatched
  • Root Cause Analysisunmatched
  • Software Administrationunmatched
  • Software Engineeringunmatched
  • Support Documentationunmatched
  • System Integration (SI)unmatched
  • Systems Engineeringunmatched
  • Teamcenterunmatched
  • Technical Supportunmatched
  • Traceabilityunmatched
  • Unified Modeling Language (UML)unmatched
  • United States Department of Energy (DOE)unmatched
  • Validation Testingunmatched

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