Systems Engineer - Medical Devices, Full Lifecycle

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

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,