Manufacturing Engineer II - North Haven, United States - ATR International

    ATR International
    ATR International North Haven, United States

    4 weeks ago

    Default job background
    Description


    We are seeking a Manufacturing Engineer II for a very important client 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

    Requirement:

    Must Have:
    Minimum Requirements


    • Bachelors degree in engineering or equivalent required
    • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experienceNice to Have
    • BS in Engineering
    • 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&TTop 3 technicalskills that you are required for this role:1.Experience working with statistical analysis tools to include Minitab, DOE, process capability, measurement system and confidence interval analysis2.Process V&V, IQ, OQ, PQ and TMV3.
    Knowledge of DFMEA and PFMEA, process mapping and critical to quality reviewsEducation Required:
    Engineering or equivalent experience Years'

    Experience Required:
    >2 years