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    Manufacturing Engineer - New York, United States - Hire IT People

    Hire IT People
    Hire IT People New York, United States

    3 weeks ago

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    Description
    Overview
    Join the Process Development Team to develop implantable cell encapsulation devices for delivering proprietary cells.
    Key Responsibilities

    • Design and develop equipment, processes, and control systems for production and assembly.
    • Manage evaluation and selection of new equipment/technologies.
    • Support ongoing optimization and improvement in equipment/systems/processes.
    • Establish operating specifications, define process windows, and improve manufacturing techniques/processes.
    • Provide support to nonengineering Staff for successful technology transfer.
    • Write and report Protocols, Reports, SOP's, and Work Instructions.
    • Statistically characterize processes and implement controls for consistency.
    • Design 3D CAD models, create drawings, and collaborate with vendors.
    • Provide troubleshooting, process, and manufacturing assistance.
    • Comply with regulatory, corporate, and Quality System policies.
    • Support Deviation Management, CAPA, and Change Control activities.
    • Perform other duties as assigned.
    Qualifications

    • BS or MS in engineering or relevant discipline.
    • 5+ years of experience (3+ with Masters) in process development within medical device or GMP regulated industry.
    • Experience leading and managing new process development initiatives.
    • Understanding of cGxP principles and practices, ISO standards, and 21CFR820.
    • Proficiency with 3D CAD software, preferably Solidworks.
    • Strong statistical knowledge, technical writing, and presentation skills.
    • Handson problemsolving approach, Sixsigma Green Belt/DMAIC experience preferred.
    • Ability to work independently, multitask, and support multiple projects.
    • Strong interpersonal, presentation, and teamwork skills.

    Desired Skills:
    Familiarity with ISO 13485, ISO 14971.
    Knowledge of global cGMP requirements.
    Six-sigma Green Belt or DMAIC problem-solving experience.
    Proficiency in Solidworks or similar 3D CAD software.
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