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Santa Rosa

    Senior Manufacturing Engineer - Santa Rosa, United States - Meet

    Meet
    Meet Santa Rosa, United States

    4 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Responsibilities:

    • Develop manufacturing processes for new products and modifications to existing ones.
    • Create fixtures and tooling necessary for the manufacturing process.
    • Execute process validation protocols (IQ/OQ/PQ).
    • Analyze process data to enhance process capability and Design for Manufacturability (DFM).
    • Conduct Installation Qualification (IQ) equipment protocols and prepare related reports.
    • Evaluate the advantages and specifications of capital equipment and justify capital appropriation.
    • Maintain accurate documentation including concepts, designs, tool drawings, and shop orders in collaboration with Quality Assurance and R&D departments.
    • Offer engineering support to production for troubleshooting and resolving technical issues.
    • Communicate with suppliers to address component and raw material concerns.
    • Assist manufacturing and quality teams in addressing Non-Conforming Material Report (NCMR) issues.
    • Manage projects in alignment with business objectives.
    • Contribute to the company's intellectual property through invention and patent applications.
    • Stay updated on medical, technical, and biomedical advancements relevant to company products.
    • Support prototype and pilot production efforts for new products, modifications, and enhancements.
    • Collaborate with product development to ensure designs are manufacturable and resolve any associated issues.
    • Maintain compliance with Good Manufacturing Practices (GMP) pertaining to Document Control, R&D, and Quality Assurance.
    • Uphold company policies, procedures, and regulatory requirements, including FDA regulations.
    • Provide coaching and mentorship to engineers, assisting in their development.
    • Identify and mitigate hazards associated with process Failure Mode and Effects Analysis (FMEA).
    • Fulfill other duties as assigned by supervisor.

    Qualifications:

    • Exercise judgment within established practices and policies.
    • Proficiency in using moderate to advanced statistical techniques for data analysis and decision-making.
    • Knowledge of statistical tools like Minitab, JMP, or equivalent.
    • Familiarity with Solid works or other CAD software (preferred but not required).
    • May establish methods and procedures for new assignments and offer guidance to junior staff.
    • Address complex problems requiring in-depth evaluation of various factors.

    Education:

    • Bachelor of Science degree in Engineering or a related technical field.

    Experience:

    • Five years of relevant experience with a Bachelor's degree, or three years with a Master's degree.
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