Project Engineer III - Medical Device Risk & URRA

Creative Solutions Services, LLC; Antioch (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior URRA lead to coordinate use-related risk analyses across programs. You will work with human factors, quality, clinical, medical safety, development, and manufacturing to document hazards, use scenarios, risks, and mitigations, and ensure timely inputs from teams.

Responsibilities include planning URRA activities, driving cross-functional collaboration, monitoring milestones, and delivering inspection-ready design-control documentation.

Qualifications

• Demonstrated ability to resolve key project hurdles using available information and technical expertise.
• End-to-end product development experience in combination product or medical device development; familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR preferred.
• Systems Engineering principles including user and stakeholder need definition, requirements definition, risk management, product architecture, configuration management, traceability, and change management.
• DHf management and creating Design Control documents in compliance with applicable regulations.
• Working knowledge of use-related risk analysis, human factors, and risk management methodologies.
• Strong organizational, facilitation, and communication skills with the ability to influence across a matrixed organization.

Responsibilities

• Lead planning and coordination of URRA activities across assigned programs.
• Facilitate cross-functional meetings to drive URRA development and timely inputs.
• Partner with functional experts to document hazards, use scenarios, risks, and mitigations.
• Monitor milestones and elevate risks, delays, and issues to stakeholders.
• Support URRA documentation to ensure inspection-ready records for the URRA owner.
• Drive consistency and continuous improvement in URRA processes.

Skills

use-related risk analysis

human factors

risk management

product development

project scheduling

Education

BS in Engineering/Science or related discipline

MS in Engineering/Science or related discipline

Tools

Document management systems

Project tracking tools

Job description

Creative Solutions Services, LLC is seeking a senior URRA lead to coordinate use-related risk analyses across programs. You will work with human factors, quality, clinical, medical safety, development, and manufacturing to document hazards, use scenarios, risks, and mitigations, and ensure timely inputs from teams.

Responsibilities include planning URRA activities, driving cross-functional collaboration, monitoring milestones, and delivering inspection-ready design-control documentation.