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- 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
- 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
Manufacturing Engineer II - North Haven, United States - IntePros Consulting
Description
Manufacturing Engineer IIContract RoleW2 onlyNo C2c On-site andTop 3 technical skills that are required for this role:Education Required:
Engineering degree requiredYears'
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.