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    Manufacturing Engineer II - North Haven, United States - IntePros Consulting

    IntePros Consulting
    IntePros Consulting North Haven, United States

    4 weeks ago

    Default job background
    Description
    Manufacturing Engineer II

    Contract Role

    W2 only

    No C2c

    On-site and


    Top 3 technical skills that are required for this role:


    • Validation and procedure design experience (IQ, OQ, MSA, TMV, PQ, FAT, SAT, SOP)
    • Significant experience in assembly equipment technologies and trouble shooting skill for CAPA, Root Cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts
    • Statistical analysis tools knowledge to include Minitab, DOE, process capability, measurement system and confidence interval analysis

    Education Required:
    Engineering degree required

    Years' Experience Required: 4+

    The Manufacturing Engineer will be working with highly motivated team members and dynamic work environment.

    This is a great opportunity to interact and work with broad cross-functional groups including different manufacturing sites engineering, quality, share-services, marketing team and extensive business platforms, and suppliers to continuously improve the manufacturability.

    A Day in the Life

    Responsibilities may include the following and other duties may be assigned.


    • Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
    • Design arrangement of machines within plant facilities to ensure most efficient and productive layout.
    • Design sequence of operations and specific procedures for the fabrication of tools and equipment and other functions that affect product performance.
    • Adapt machine or equipment design to factory and production conditions.
    • May incorporate inspection and test requirements into the production plan.
    • Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigate and initiate corrective action of problems and deficiencies to ensure product quality.
    • Develop manufacturing processes that are applicable to statistical process control, and may develop those techniques.
    • Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
    • Ensure processes and procedures are in compliance with regulations.
    • Experience with FDA 21 CFR part 820, ISO 13485, ISO 14971 and GMP
    • Experience working with statistical analysis tools to include Minitab, DOE, process capability, measurement system and confidence interval analysis
    • Process V&V, IQ, OQ, PQ and TMV
    • Knowledge of DFMEA and PFMEA, process mapping and critical to quality reviews
    • Demonstrated knowledge DFA/DFM, design and manufacturing documentation to include specifications, procedures, sampling methods, tolerance studies and GD&T
    • PTC Creo or Solidworks
    • CAPA, root cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts
    • Experience or knowledge of engineering drawings and GD&T
    • Traveling maybe required
    #LI-RS1
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