Systems Engineer (medical devices)

Katalyst CRO; Plymouth (MN); On-site; USD 95,000 - 135,000; Full time

Job summary

Katalyst CRO seeks a Systems Engineer to steer the technical direction of Acute Therapies products across the full lifecycle, from feasibility through post-market. You will focus on requirements management, risk analysis, system integration, and verification/validation within a regulated medical-device environment.

Ideal candidates bring strong systems engineering foundations, experience with electro-mechanical or software-integrated systems, and proficiency with DOORS, Teamcenter, TrackWise8,

Qualifications

• Understanding of systems engineering principles and lifecycle.
• Experience with electromechanical and software-integrated systems.
• Knowledge of requirements management and traceability.
• Familiarity with risk management and reliability engineering.
• Experience with connected devices and cybersecurity concepts (preferred).
• Proficiency with tools such as DOORS, Teamcenter, TrackWise8, JIRA/ALM.

Responsibilities

• Support systems engineering across product lifecycle from NPD to post-market.
• Translate clinical and user needs into product requirements.
• Gather and manage requirements from regulatory, quality, manufacturing, service.
• Drive system-level design and product realization using best practices.
• Develop design concepts and research methodologies aligned with 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 fishbone diagrams and Pareto charts.
• Assess impact of changes and recommend solutions.
• Collaborate with cross-functional teams and stakeholders.
• Ensure compliance with FDA, ISO, IEC design control standards.

Skills

Systems engineering

Electro-mechanical

Requirements management

Risk management

Traceability

Security concepts

DOORS

SysML/UML

Education

Bachelors in Electrical Engineering

Bachelors in Mechanical Engineering

Bachelors in Biomedical Engineering

Software Engineering

Masters degree

Tools

DOORS

Teamcenter

TrackWise8

JIRA / ALM

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.
• 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

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