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    Lead Manufacturing Engineer - Irvine, United States - Broadley-James

    Broadley-James
    Broadley-James Irvine, United States

    3 weeks ago

    Default job background
    Description


    Broadley-James Corporation designs and manufactures pH and dissolved oxygen sensors for biopharmaceutical companies involved in fermentation and large scale cell culture applications.

    We service a worldwide customer base and provide in-depth technical support as well as superior sensor products to a demanding industry.


    We are seeking a Lead Manufacturing Engineer is responsible for designing, implementing, and reviewing the procedures and equipment involved in the manufacturing process of assigned products.


    Schedule:
    M-F, 7:30AM-4:00PM


    Tasks/Responsibilities:
    Directly supervises and collaborates with the Process Engineer in defining the requirements and verification/validation of processes and/or equipment.

    Completes the design and fabrication of Production fixtures and jigs in SolidWorks during initial design, design improvements, or scaling up designs.

    Acts as a member of the Change Control Board to present, review, and/or approve manufacturing process changes and improvements of assigned products.

    Supervises the development of computer-aided design (CAD) and SolidWorks project drawings from staff engineers and related contractors.
    Ensures computer-aided design (CAD) files are maintained according to good documentation practices and established Quality Assurance procedures.
    In conjunction with in-house product experts, establishes and maintains necessary procedures to ensure that the device design - its components and configuration - is correctly translated into production specifications


    Related tasks include:
    Properly verifying and validating test plan, procedures, and test fixture documentation
    Completing process validation reports
    Performing and documenting a product-failure mode and effects analysis
    Confirming sufficient completion of final acceptance test reports
    Completing materials inspection plan, including necessity of first-article inspection and validation of in-process and final inspection plans

    Transfers the product design into production methods and procedures, in conjunction with Production, Engineering, Quality and related vendors/3rd Responsibilities include:

    Ensuring all part drawings and schematics are complete and ready for production
    Ensuring all standard component specifications are available for off-the-shelf parts
    Ensuring specifications and drawings are available for all custom parts
    Confirming that all parts have been assigned part numbers
    Confirming complete assembly procedures are finalized and readily available
    Determination of estimated time required to manufacture the device
    Determination of how many devices will be produced and according to what schedule


    Contributes to and supports a compliant Production environment including regulatory adherence, vendor qualification efforts, materials inspections, safety tests, ISO 13485 compliance, and CAPA system management.

    Constantly interacts with peers and senior leadership on the various individual projects associated with the above tasks.


    Abilities:


    Able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist, and creative thinking is required.

    Able to lead and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements.
    Capable of operating independently with minimal technical direction
    Able to take direction and execute plans.
    Able to work in a changing environment and communicate changes.
    Superior organizational and communication skills
    Good written and verbal skills.


    Physical Demands:


    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Must be able to stand, sit, and walk for long periods of time.

    Must be able to climb stairs/ladders, balance, stoop, kneel, crouch, talk, hear, type, and reach with both hands and arms repetitively throughout the day.

    Must have good vision (close, color vision, peripheral, depth perception, adjust focus).
    Must be able to lift, push and pull up to 15 lbs. periodically throughout the day.


    Preferred Experience/Minimum Qualifications:
    Minimum Requirements of employee (education, previous use of specific equipment/technologies, prior experience etc.)

    Proven track record of successfully delivering new product/s through entire development cycle in a manufacturing environment.
    Knowledge of product development processes (PDP) - VOC to product launch
    Prior experience working within QMS design control processes.
    Practical knowledge of ISO 9001/13485
    Prior experience managing remediation and requirements of legacy products.
    Must be able to read, write, and speak in English.
    Minimum of 5 years' experience using SolidWorks, including 2 years of SolidWorks PDM.
    Prior experience with participating in Risk Assessments.
    Familiarity of PDM Vault preferred.
    Working knowledge of GMP requirements and best industry practices preferred.
    Previous management experience preferred.

    Broadley-James Corporation offers many benefits including:
    Competitive salaries
    Medical, dental, vision, and life insurance
    401(k) plan
    Education assistance
    Corporate sponsored discounted gym membership
    9+ paid holidays per year
    Vacation and sick pay

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