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    Staff NPI Process Engineer - San Jose, United States - bioMérieux SA

    bioMérieux SA
    bioMérieux SA San Jose, United States

    1 week ago

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    Description


    The Staff NPI Process Engineer will own new products during pilot phase and will work with a cross functional to evaluate product requirements and available technologies to develop processes and transfer to manufacturing.

    This is a hands-on position involving process characterization, validation, and transfer to production with the ability to interface well with engineers, scientists, and operations personnel in a high-volume manufacturing and fast-paced FDA regulated environment.


    PRIMARY DUTIES:
    Owns new products during pilot production phase through successful and sustained project launch. This includes driving new product introduction schedules, resolving manufacturability issues, and driving improvements.

    Must have the ability to succeed in a fast-paced environment: Be flexible and adaptable within a changing and dynamic environment with ambiguous scope.

    Partner with cross functional teams to evaluate new product, processes, and equipment design at concept phase and define manufacturing processes.

    Develop new and/or improved processes for parts and assemblies through the application of theoretical and practical engineering.
    Extensive knowledge of equipment and methods to implement assembly and test processes of complex medical devices.
    Coordinate and perform process characterization studies & DOE's to develop process window and/or improve existing assembly processes.
    Test, and validate new automation processes and/or designs in collaboration with a diverse functional team of engineers and scientists.

    Write Verification/Validation protocols (IQ/OQ/PQ) and related technical reports to support the transfer of new products, processes, and equipment into production.

    Perform failure investigations and root cause analyses as they relate to process performance.
    Use statistical analysis, and hands-on bench or line testing to characterize attributes, process performance, and equipment assembly characteristics.
    Create and/or update SOP/DOP and train MFG personnel to new processes and automated equipment during product transfer phase.
    Drive data review and electronic documentation change control process


    QUALIFICATIONS:
    Minimum Bachelor's degree with 7+ years of relevant experience in medical device regulated manufacturing environment, or Master's degree with 5 years of relevant work experience of relevant experience in medical device regulated manufacturing environment, or equivalent combination of education and experience to perform at this level
    Demonstrated understanding of manufacturing processes including injection molding, machining, liquid dispensing, welding, design of experiments, and capability analysis
    Hands on experience with high volume automated manufacturing equipment.
    Previous working experience supporting manufacturing lines in high volume medical device manufacturing environment
    Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
    Experience with lean manufacturing and Six Sigma techniques (5S, MUDA, Kaizen, Visual Management, Daily management)
    Basic mechanical and electro-mechanical troubleshooting skills of automated manufacturing equipment
    Proven experience with DOE creation, root cause analysis, process engineering, failure investigations and automated assembly equipment.
    Experience in process characterization and development, acceptance testing and qualification of automated equipment.
    Proficient with performing root cause analysis (fishbone diagram, 5-Whys)
    Experience with Quality Management System and electronic document change control required
    Must have strong computer skills, including all MS Office applications, electronic NCs, ERP system, learning portal and training
    Must be proficient in document preparation and editing, including detailed test planning and report writing.
    Excellent verbal and written communication skills to present summary data to cross functional team
    Experience with statistical analysis software (MiniTab or similar)
    Experience with updating BOMs, product specifications
    Project management experience would be a plus.
    The estimated salary range for this role based in California is between $122,400 and $152,400 annually.

    This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program.

    This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living.

    Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.

    A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
    Company-Provided Life and Accidental Death Insurance
    Short and Long-Term Disability Insurance
    Retirement Plan including a generous non-discretionary employer contribution and employer match.

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