Systems Engineer (medical devices)

Katalyst Healthcares & Life Sciences • Contract • Plymouth, MN, US • 22h ago

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

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