Manufacturing Engineer

2 weeks ago


North Haven, United States ATR International Full time

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.

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 experience Nice 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&T

Top 3 technical skills 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 analysis 2. Process V&V, IQ, OQ, PQ and TMV 3. Knowledge of DFMEA and PFMEA, process mapping and critical to quality reviews

Education Required: Engineering or equivalent experience

Years’ Experience Required: >2 years

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