Medical Device Systems Engineer — Contract, MN, 10 PTO

Stefanini North America and APAC; Plymouth (MI); On-site; USD 69,000 - 73,000; Full time

Benefits offered by this job

PTO 10 days

Job summary

Stefanini North America and APAC is seeking a Systems Engineer (contract) to guide the technical direction of Acute Therapies products. You will drive design realization, requirements management, risk assessment, and system integration across the product lifecycle.

You will collaborate with global teams, ensuring adherence to FDA, ISO and IEC design controls, while leveraging SysML/UML, DOORS, Jama and other tools to maintain DHF elements and verification artifacts.

Qualifications

• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical or related engineering/science.
• Three+ years of relevant experience in medical devices or regulated products.
• Experience with system modeling and requirement management tools.

Responsibilities

• Perform systems engineering across product lifecycle from development to post-market surveillance.
• Understand user needs and regulatory requirements to guide design realization.
• Capture and manage inputs for requirements from diverse sources (regulatory, quality, manufacturing, service).
• Develop design concepts and drive risk management and verification activities.
• Maintain design history files and ensure traceability per FDA/ISO/IEC standards.
• Collaborate with cross-functional teams to mitigate technical risks and deliver results.

Skills

Systems engineering

Electro-mechanical

Software engineering

SysML/UML

Requirements management

Cross-functional teams

Education

Bachelor's/Master's in Engineering/Science

Tools

DOORS

Jama

Teamcenter

TrackWise8

JIRA

ALM

Job description

Stefanini North America and APAC is seeking a Systems Engineer (contract) to guide the technical direction of Acute Therapies products. You will drive design realization, requirements management, risk assessment, and system integration across the product lifecycle.

You will collaborate with global teams, ensuring adherence to FDA, ISO and IEC design controls, while leveraging SysML/UML, DOORS, Jama and other tools to maintain DHF elements and verification artifacts.