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    Associate Principal NPI Engineer - San Jose, United States - BioFire Diagnostics

    BioFire Diagnostics
    BioFire Diagnostics San Jose, United States

    3 weeks ago

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    Description

    PRIMARY DUTIES


    During the initial phase of a product development process (PDP), the engineer plans and documents development of new processes following PDP procedure through change control.

    Contributes to the design and development of robust, reliable, effective and efficient processes.

    Owns new product introduction during pilot production phase through successful and sustained project launch. This includes meeting new product introduction schedules, and resolving manufacturability issues.

    Engineer may need to engage with equipment vendors to facilitate tool acquisition, installation, and qualification.


    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

    KNOWLEDGE, EXPERIENCE & SKILLS

    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 setting up, commissioning and optimization of manufacturing equipment.

    Previous working experience supporting product development processes from initial state.

    Previous working experience supporting medical device manufacturing lines.

    Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.

    Hands-on 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.

    Working experience with 3D design packages (Solidworks, Inventor, Pro E)

    Hands-on experience with semi-automated equipment troubleshooting, root cause analysis, equipment engineering, failure investigations and manufacturing assembly equipment.

    Proven experience with mechanical design concepts, machinery and automation: Electrical, Mechanical, and Electromechanical schematics, motors, pumps, vacuum, and hydraulics

    Experience with Quality Management System and electronic document change control required

    Must have strong computer skills, including all MS Office applications, 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 (JMP, MiniTab or similar)

    Experience with updating BOMs, product specifications
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