Manufacturing Engineer - North Haven, United States - ATR International

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.

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