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Project Engineer

Karwell Technologies

  • Lake County, IL
  • 30+ days ago

    Highlights

    Ideal candidates will have experience with drug product delivery systems, combination products, human factors engineering, and regulated product development. 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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