Systems Engineer

Karwell Technologies

  • Plymouth, MN
  • 30+ days ago
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    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

    Description

    Job Description:
    • 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

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