Manufacturing Engineer II
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.
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 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 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 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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