Manufacturing Engineer
2 weeks ago
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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