Manufacturing Engineer II
📋 Role Overview & Responsibilities
Job Description
Top 3 technical skills that are required for this role
Validation and procedure design expérience (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
Education Required: engineering degree required
Years’ 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.
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
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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This position is located in North Haven, CT with potential relocation and sponsorship assistance depending on candidate qualifications.
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