Manufacturing Tooling Engineer - Raynham - E-Solutions

    E-Solutions
    E-Solutions Raynham

    1 day ago

    Description

    Job Title:
    Manufacturing Tooling Engineer


    Location:
    Raynham, MA

    JD as below


    • Looking for a mechanical/manufacturing engineer
    • Experience with process validation required
    • Experience with GD&T, CMM, gaging required
    • Experience with statistical analysis/Minitab preferred
    • Experience with CAD, NX preferred
    • Experience with Windchill preferred
    • Experience with fixture/gage design is a plus
    • Wax injection tooling/injection molding experience is a plus
    • Foundry experience is a plus
    Required Qualifications

    Education:
    Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.


    Experience: 3-7 years in manufacturing tooling, fixtures, gages, injection molding equipment validation in a regulated environment (MedTech, pharma, or healthcare devices).


    Regulatory & Standards:

    Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO and validation concepts (IQ/OQ/PQ).


    Technical Skills:
    o Proficiency in developing and executing IQ/OQ/PQ protocols.
    o Experience with fixtures, gages, injection molding,
    o Statistical tools experience (Minitab, JMP, or similar) for process capability studies.
    o Document control and eQMS systems experience (e.g., MasterControl, ETQ, etc.).

    Communication:
    Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams.

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