About the role
Summary:
We are looking for an experienced Project Engineer with a strong background in pharmaceutical, medical device, combination products, or other regulated industries.
Roles & Responsibilities:
- 5+ years of experience in regulated industry environments (Pharma / Medical Device / Combination Products)
- Strong expertise in Design History File (DHF) management and Design Control documentation
- Experience with Use-Related Risk Analysis (URRA), Human Factors, and Risk Management
- Knowledge of FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR preferred
- Experience supporting end-to-end product development from concept through market release
- Strong project coordination, communication, facilitation, and stakeholder management skills
- Lead planning and coordination of Use-Related Risk Analysis activities
- Facilitate cross-functional collaboration with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams
- Support documentation of hazards, use scenarios, failure modes, risks, and mitigations
- Drive Design Control, Systems Engineering, and Quality by Design (QbD) activities
- Support system architecture, requirements definition, traceability, risk assessments, and change management
- Manage project schedules, risks, mitigation plans, and vendor communications
Education & Experience:
- BS in Engineering, Science, or related discipline with 10+ years of relevant experience
- MS with 8+ years of relevant experience
- Ideal candidates will have experience with drug product delivery systems, combination products, human factors engineering, and regulated product development.
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