Senior Process Development Engineer

Katalyst Healthcares & Life Sciences

  • Cincinnati, OH
  • 17 days ago

    Highlights

    We are seeking 5 Mid to Senior Process Development Engineers with 10+ years of medical device experience to lead the development and commercialization of innovative drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, auto-injectors, and micro-infusion pump systems. The engineer will provide technical leadership across the full product development lifecycle, from concept and design through verification, validation, regulatory approval, and commercialization.

    Numbers & Facts

    LocationCincinnati, OH

    Description

    Summary :
    We are seeking 5 Mid to Senior Process Development Engineers with 10+ years of medical device experience to lead the development and commercialization of innovative drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, auto-injectors, and micro-infusion pump systems.
    The engineer will provide technical leadership across the full product development lifecycle, from concept and design through verification, validation, regulatory approval, and commercialization.

    Roles & Responsibilities :
    • Lead cross-functional teams in the design and development of mechanical and electro-mechanical medical devices.
    • Drive products from concept through commercialization, including verification, validation, and regulatory submissions.
    • Develop engineering specifications, design documentation, project plans, test protocols, and validation plans.
    • Support design controls, risk management, process validation, and continuous improvement initiatives.
    • Collaborate with Marketing, Operations, Quality, and R&D teams.
    • Provide technical leadership and mentor junior engineers.
    • Support FDA and international regulatory submission activities.
    Education & Experience :
    • 10+ years of medical device engineering experience.
    • Strong experience with electro-mechanical medical device design and commercialization.
    • Proven experience leading products through FDA 510(k), PMA, and CE Mark approvals.
    • Strong knowledge of design controls, risk management, verification, validation, and quality systems.
    • Experience leading cross-functional engineering/product development teams.

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