Systems Engineer (medical devices) Job at Katalyst HealthCares and Life Sciences, Plymouth, MN

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  • Katalyst HealthCares and Life Sciences
  • Plymouth, MN

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

Job Tags

Full time

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