Project Engineer III
Illinois, United States
Job Description
Roles & Responsibilities:
Requirements:
Preferred Experience:
Top 3 - 5 Skills Needed for each role:
- 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 escalate 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.
- bility 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.
- bility to multitask effectively and deliver results within established timelines.
Top 3 - 5 Skills Needed for each role:
- Working knowledge of use-related risk analysis, human factors, risk management, or product development preferred
- 5+ years of experience in pharmaceutical, medical device, combination product, or other regulated industry environments.
- Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.
- Strong organizational, facilitation, and communication skills.
- Familiarity with relevant human factors and risk management expectations.
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