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    Reliability Engineer-Process - Milpitas, United States - TEPHRA

    TEPHRA
    TEPHRA Milpitas, United States

    3 weeks ago

    Default job background
    Description
    :

    Job Title Reliability Engineer

    Relevant Experience

    (in Yrs) 6+

    Technical/Functional Skills


    • Skills in the application of statistics, including experience with Minitab
    • Working skills in
    :

    inspection qualification methods, sampling plans, inspection techniques, process validation


    • Skills in process control & other process monitoring activities
    Experience Required


    • Knowledge of statistical process control and other process monitoring methods and techniques
    • Strong understanding of and experience in the application of statistics, including experience with Minitab
    • Knowledge of GR&R, inspection qualification methods, sampling plans, inspection techniques, critical attributes, process validation, trending methods, environmental monitoring, etc.
    Roles & Responsibilities


    • Review plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory) to ensure provisions for quality are addressed & resolved prior to product release
    • Work with R&D and the project team to develop, review and approve appropriate verifications (DVT) for both new design and changes to released product.
    • Perform statistical analysis of data and technical support for performing testing
    • Assess reliability in bench, lab, and/or clinical settings, producing full traceability of reliability assessment evidence to performance measures, metrics and requirements.
    • Develop reliability growth and verification test plans, accelerated testing methods, statistical data analysis methods and test equipment concepts to support product and subsystem reliability growth and evaluation.
    • Review and approve changes to designs/processes and assess impact on product and qualification status
    • Ensure team compliance of relevant safety regulations, QSRs, ISO Standards, MDD, and key FDA/MDD guidance documents
    • Ensure technical documentation meets requirements of the regulation such as ISO 13495 and FDA CFR820
    Generic Managerial Skills


    • Must have strong organizational, analytical and problem-solving skills
    • Must have keen time management skills
    • Ability to work in a team proactively, flexibly in an environment
    Education


    • B.S. in Engineering
    • Minimum 4 years of experience in Reliability Engineering. 2+ years of experience working with medical device products and in the healthcare industry
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