Project Engineer

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.