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Mechanical Design Engineer

Katalyst Healthcares & Life Sciences

  • Denver, CO
  • 30+ days ago

    Highlights

    Roles & Responsibilities: Lead new product development from proof-of-concept through design verification for a needle-free drug delivery application, following a stage-gate NPD process. Create, refine, and release 3D models and production drawings for disposable and syringe-based components using SolidWorks.

    Numbers & Facts

    LocationDenver, CO

    Description

    Roles & Responsibilities:
    • Lead new product development from proof-of-concept through design verification for a needle-free drug delivery application, following a stage-gate NPD process
    • Create, refine, and release 3D models and production drawings for disposable and syringe-based components using SolidWorks
    • Author and maintain Design History Files (DHF) and support audits, inspections, and regulatory compliance activities
    • Ensure adherence to ISO and FDA design control requirements throughout the development process
    • Optimize designs for manufacturability and scale-up in collaboration with contract manufacturers and key suppliers
    • Manage prototype builds, testing iterations, and design refinements through vendor engagement and validation activities
    Education & Experience:
    • bachelor's degree in mechanical engineering
    • Minimum of 2+ years of mechanical design experience, preferably in medical devices within a regulated environment
    • Proficiency in SolidWorks
    • Working knowledge of ISO and FDA design controls
    • Experience supporting new product development from concept through testing and validation

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