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Project Engineer

Katalyst Healthcares & Life Sciences

  • Lake County, IL
  • 13 days ago

    Highlights

    Ideal candidates will have experience with drug product delivery systems, combination products, human factors engineering, and regulated product development. Summary: We are looking for an experienced Project Engineer with a strong background in pharmaceutical, medical device, combination products, or other regulated industries.

    Numbers & Facts

    LocationLake County, IL

    Description

    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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