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    Sr. Manufacturing Engineer - West Jordan, United States - Route 92 Medical

    Route 92 Medical
    Route 92 Medical West Jordan, United States

    3 weeks ago

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    Description
    Job Description

    Job Description


    PURPOSE OF JOB:


    Lead SLC site-specific technical engineering projects that create, design, develop, sustain, and improve production capabilities for coating, manufacturing, and assembly operations.

    Support the product transfer plans for products planned for SLC per company/site objectives.

    Collaborate with cross-functional teams on process enhancement for continuous improvement of SLC process capabilities for safety, quality, capacity, and readiness for new product transfers.


    RESPONSIBILITIES:


    Design and develop manufacturing processes for new and existing products, product changes and enhancements, and related tooling and fixtures modifications.

    Perform/manage validations on equipment (IQ/OQ/PQ) and processes as well as creating test protocols in collaboration with Quality Systems and preparing reports.

    Prepare document change orders (DCR) and coordinate the deployment of changes including training operation team members and improvement of manufacturing process instruction, forms, and logs.

    Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality, and safety performance for both current and new products.

    Support prototype and pilot production at SLC of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.

    Coordinate with site leadership, facilities, outside service providers and other subject-matter-experts to ensure reliability and performance of process equipment to deliver product to desired specifications.

    Work with product development as assigned to ensure that products under development are optimally manufacturable and to resolve manufacturing issues for future product transfers to SLC.

    Maintain GMP systems, including pre-production quality assurance as well as post-production GMP compliance in coordination with Document Control, R&D, and Quality Assurance functions.

    Complete accurate and timely manufacturing documentation including manufacturing procedures, materials records, validations, test reports, etc.
    Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.


    PREFERRED EDUCATION:
    Bachelor's Degree in Engineering, Materials, or Science required. Advanced degrees (MS/MBA) desirable.


    PREFERRED EXPERIENCE:
    Minimum of 5 years of experience preferably in the regulated Medical Device or Aerospace industry.
    Knowledge of industry standard processes for assembly, specialty coating, and packaging of catheter systems.
    Proven project management experience contributing as either team leader, team member, or contributor.


    ADDITIONAL SKILLS:
    Excellent communication, cross-functional team, interpersonal, and time management skills required.
    Training/certifications

    in Lean/Six-Sigma, Project Management, Statistics desirable.
    Ability to work independently or in a team setting as needed.

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