URRA Systems Engineer — Medical Device Risk & Design

JobDiva, Inc.; North Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

JobDiva, Inc. is seeking a Systems Engineer focused on Use-Related Risk Analysis (URRA) for drug products and delivery systems.

You will coordinate URRA activities, integrate inputs from human factors, quality, clinical, medical safety, development, and manufacturing, and drive risk-based design decisions to ensure patient-centered products. You will partner with a global team to ensure compliance with internal procedures and regulatory requirements, including design controls, QbD, and risk

Qualifications

• Experience in pharmaceutical/medical device development (5+ years).
• Familiarity with FDA 21 CFR Part 820.30 and ISO 14971.
• Ability to lead URRA activities across programs.
• Proven ability to coordinate cross-functional teams.
• Experience with Design Control and DHF management.
• Strong analytical, writing and verbal communication skills.
• Experience with vendor management and external partners.
• Multitask and meet tight timelines.

Responsibilities

• Lead planning and coordination of URRA activities across programs.
• Facilitate cross-functional meetings to develop URRA analyses.
• Document hazards, use scenarios, failure modes, risks, and mitigations.
• Monitor milestones and escalate risks or issues early.
• Support URRA documentation to ensure inspection readiness.
• Drive consistency and identify process improvements in URRA.
• Support system architecture, requirements, traceability, and risk management.
• Coordinate change management and third-party development integration.

Skills

URRA leadership

Risk management

Systems engineering

Regulatory alignment

Cross-functional coordination

Documentation planning

Project planning

Vendor management

Education

BS in Engineering

MS in Engineering (optional)

Job description

JobDiva, Inc. is seeking a Systems Engineer focused on Use-Related Risk Analysis (URRA) for drug products and delivery systems.

You will coordinate URRA activities, integrate inputs from human factors, quality, clinical, medical safety, development, and manufacturing, and drive risk-based design decisions to ensure patient-centered products. You will partner with a global team to ensure compliance with internal procedures and regulatory requirements, including design controls, QbD, and risk