Project Engineer III

JobDiva, Inc.; Antioch (IL); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

use-related risk analysis

human factors

risk management

product development

project scheduling

Formation

BS in Engineering/Science or related discipline

MS in Engineering/Science or related discipline

Outils

Document management systems

Project tracking tools

Description du poste

Roles & Responsibilities:

• Lead planning and coordination of creating use-related risk analysis activities across all assigned programs.
• Facilitate cross-functional meetings to drive development of use-related risk analyses, ensuring team members provide timely inputs for which they are responsible.
• Partner with functional experts — including human factors, quality, clinical, medical safety, development, and manufacturing — to support accurate documentation of hazards, use scenarios, failure modes (i.e., use errors), risks, and mitigations.
• Monitor progress against milestones and proactively elevate risks, delays, and unresolved issues to appropriate stakeholders.
• Support team development and review of URRA documentation to ensure delivery of inspection-ready records to the URRA owner.
• Drive consistency in URRA process execution and continuously identify opportunities for process improvement.
• System Architecture & Integration
• User and Stakeholder Needs Definition
• Use Case Analysis
• Standards Coverage Analysis
• Product Requirements Definition
• Traceability
• Risk Management planning and reporting
• System Risk Assessment
• Use-Related Risk Assessments, Design FMEAs, and Process FMEAs
• Change Management
• Oversight and integration of Third-Party Development activities
• Integration of Design Control and Quality by Design (QbD) activities

Requirements:

• Demonstrated ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
• Expertise in end-to-end product development from initial concept through market release, with direct 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.
• Expertise in Systems Engineering principles including user and stakeholder need definition, requirements definition, risk management, product architecture, configuration management, traceability, and change management.
• Expertise in DHF management and creating various 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 and manage competing priorities.
• Strong analytical and decision-making skills; self-driven and proactive in approach.
• Experience creating and managing project schedules and identifying project risks and mitigation plans.
• Proficiency with project tracking and document management tools.
• Experience interfacing with third-party vendors, including communication management, deliverable acceptance testing, and multi-cultural awareness.

Preferred Experience:

• Experience supporting drug product and delivery system development.
• Familiarity with relevant human factors and risk management regulatory expectations.
• Ability to synthesize complex technical input into clear, actionable plans and documentation.
• Demonstrated proactive, collaborative approach in a fast-paced, highly matrixed environment.
• Experience in vendor communication, management, and deliverable acceptance testing.
• BS in Engineering, Science, or a closely related discipline with 10+ years of relevant experience; or MS with 8+ years of experience.
• 5+ years of experience specifically in pharmaceutical, medical device, combination product, or other regulated industry environments preferred.
• Demonstrated scientific writing skills and strong verbal communication skills.
• Ability to multitask effectively and deliver results within established timelines.

Top 3 – 5 Skills Needed for each role:

1. Working knowledge of use-related risk analysis, human factors, risk management, or product development preferred
2. 5+ years of experience in pharmaceutical, medical device, combination product, or other regulated industry environments.
3. Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.
4. Strong organizational, facilitation, and communication skills.
5. Familiarity with relevant human factors and risk management expectations.