Systems Engineer

Karwell Technologies

Plymouth, MN

JOB DETAILS
SKILLS
Aerospace and Defense, Analysis Skills, Atlassian JIRA, Best Practices, Biomedical Engineering, Communication Skills, Cross-Functional, Documentation, Electrical Engineering, Electromechanics, FDA (Food and Drug Administration), File Maintenance, ISO (International Organization for Standardization), Intensive Care, International Electro-Technical Commission (IEC), Internet Security, Maintain Compliance, Manufacturing, Mechanical Engineering, Medical Equipment, Military, Multitasking, Problem Solving Skills, Product Design, Product Development, Product Engineering, Product Lifecycle, Product Management, Regulations, Reliability Engineering, Requirements Management, Risk Analysis, Risk Management, Root Cause Analysis, Software Administration, Software Engineering, Support Documentation, System Integration (SI), Systems Engineering, Teamcenter, Technical Support, Traceability, Unified Modeling Language (UML), United States Department of Energy (DOE), Validation Testing
LOCATION
Plymouth, MN
POSTED
5 days ago
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

About the Company

K

Karwell Technologies