URRA Systems Engineer II - Medical Device & Risk

The Fountain Group; North Chicago (IL); On-site; USD 133,000 - 144,000; Full time

Job summary

The Fountain Group is seeking a Systems Engineer II to join their device development team in North Chicago, IL. You will lead use-related risk analyses and coordinate cross-functional activities across human factors, quality, clinical, and manufacturing.

You will drive DHF architecture, design controls, and risk management, ensuring robust documentation and regulatory alignment for clinical and commercial programs.

Qualifications

• BS in Engineering or closely related field with 5+ years in pharma/medical device settings.
• MS in Engineering with 3+ years preferred.
• Experience with FDA 21 CFR Part 820 and ISO 13485 is preferred.
• Strong written and verbal communication skills.
• Ability to multitask and meet timelines.

Responsibilities

• Lead URRA planning and coordination across programs.
• Facilitate cross-functional URRA meetings and ensure timely inputs from team members.
• Document hazards, use scenarios, risks, and mitigations with functional experts.
• Monitor milestones and proactively elevate risks or delays.
• Ensure URRA records are inspection-ready and compliant.

Skills

URRA leadership

Design Controls

DHF documentation

Cross-functional collaboration

Regulatory awareness

Education

BS in Engineering

MS in Engineering

Job description

The Fountain Group is seeking a Systems Engineer II to join their device development team in North Chicago, IL. You will lead use-related risk analyses and coordinate cross-functional activities across human factors, quality, clinical, and manufacturing.

You will drive DHF architecture, design controls, and risk management, ensuring robust documentation and regulatory alignment for clinical and commercial programs.