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    Process Engineer - Wayland, United States - BlackTree Technical Group, Inc.

    BlackTree Technical Group, Inc.
    BlackTree Technical Group, Inc. Wayland, United States

    1 month ago

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    Description

    Job Description

    Job Description

    The role requires active participation in the NPI and sustaining manufacturing engineering organization to refine material handling, workstation design, components, assemblies, process documentation, tooling, and test methods to improve efficacy, reliability, manufacturability, and cost for advanced catheter devices.

    Key Duties

    • Act as the liaison between the R&D, Product Management, and Quality as well as component & equipment suppliers and provide "voice of manufacturing" to ensure product/equipment designs incorporate DFM/A principals and/or Lean Six Sigma/DMAIC/DMADV process knowledge.
    • Lead the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
    • This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
    • Lead and support Design Transfer to manufacturing activities.

    Required

    • Minimum B.S. (Mechanical, Electrical, or other related Engineering field equivalent)
    • Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment
    • Experience working closely with external or third-party suppliers.
    • Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments, GR&R) in data analysis for process development and problem-solving.
    • Understand equipment concept creation, review approval, build, runoff, FAT, software validation, IQ, OQ, and PQ road map requirements.
    Company DescriptionBlackTree Technical Group is a full-service staffing and recruitment firm. Our team consists of an experienced group of Senior Technical Recruiters and Account Managers with over 40 years of industry experience. Our firm prides itself on our technical knowledge, innovative sourcing strategies, and most importantly, a long-standing record of proven results for both clients and job-seekers.

    Company Description

    BlackTree Technical Group is a full-service staffing and recruitment firm. Our team consists of an experienced group of Senior Technical Recruiters and Account Managers with over 40 years of industry experience. Our firm prides itself on our technical knowledge, innovative sourcing strategies, and most importantly, a long-standing record of proven results for both clients and job-seekers.

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