Lead Systems Engineer – Use-Related Risk (Medical Devices)

Stellent IT LLC; North Chicago (IL); On-site; USD 85,000 - 110,000; Full time

Job summary

Stellent IT LLC is seeking a Systems Engineer focused on Use-Related Risk Analysis (URRA) to drive risk analyses for device and combination product development. You’ll coordinate cross-functional teams across human factors, quality, clinical, medical safety, development, and manufacturing to deliver inspection-ready URRA docs and robust risk mitigations.

You will integrate inputs to ensure patient-centric design,維 with regulatory and quality standards, supporting both clinical and commercial

Qualifications

• Experience in end-to-end product development, incl. medical device or combination products.
• Familiarity with FDA 21 CFR Part 820.30, ISO 14971, ISO 13485, EU MDR preferred.
• Strong written and verbal communication skills; scientific writing ability.
• Ability to multitask and deliver on timelines.

Responsibilities

• Lead URRA planning across programs and coordinate cross-functional activities.
• Document hazards, use scenarios, risks, and mitigations with stakeholders.
• Collaborate with human factors, quality, clinical, medical safety, development, and manufacturing teams.
• Ensure DHF architecture and Design Controls alignment across programs.
• Define system requirements, traceability, and risk management plans.
• Oversee change management and integration of third-party development.

Skills

URRA

System Architecture

Risk Management

Traceability

Vendor Liaison

Education

BS in Engineering/Science

MS with 3+ years

Tools

Project Tracking Tools

Document Management

Job description

Stellent IT LLC is seeking a Systems Engineer focused on Use-Related Risk Analysis (URRA) to drive risk analyses for device and combination product development. You’ll coordinate cross-functional teams across human factors, quality, clinical, medical safety, development, and manufacturing to deliver inspection-ready URRA docs and robust risk mitigations.

You will integrate inputs to ensure patient-centric design,維 with regulatory and quality standards, supporting both clinical and commercial