Systems Engineer (medical devices)
Plymouth, Minnesota, United States
Job Description
Summary
Required Skills & Qualifications:
- 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.
- 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
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