Manufacturing Process Engineer

    Highlights

    Job Summary: Manufacturing Process Engineer with experience in medical device manufacturing, responsible for developing manufacturing processes, performing validations, and ensuring compliance with regulatory requirements in a fast-paced environment. Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization.

    Numbers & Facts

    LocationPlano, TX

    Description

    Job Summary:
    • Manufacturing Process Engineer with experience in medical device manufacturing, responsible for developing manufacturing processes, performing validations, and ensuring compliance with regulatory requirements in a fast-paced environment.
    Roles & Responsibilities:
    • Evaluate process and design alternatives based on Design for Manufacturability principles
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
    • Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization
    • Multitasks, prioritizes, and meets deadlines in a timely manner
    • Strong organizational and follow-up skills, with attention to detail
    • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
    Education & Experience:
    • Bachelor's in Mechanical Engineering or Manufacturing Engineering or equivalent
    • Minimum experience of 4 years in Medical Devices - Manufacturing Engineering
    • Good experience working on Process Validations (IQ, OQ, PQ)
    • Experience developing manufacturing processes and technologies, including process characterization
    • Experience working on PFMEAs
    • Experience performing data analysis using Minitab

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