Manufacturing Engineer
4 weeks ago
Job Title - Sr Manufacturing Engineer
Job Location - Plymouth, Minnesota
Type: W2 contract
This is a Fully Onsite role
Job Description -
Responsibilities may include the following and other duties may be assigned.
Perform process development / process validation in support of the PMO road map.
Create and complete validation documentation and route engineering change orders.
Ability to remain self-motivated to push through required documentation to support changes.
Quickly learn and collaborate on product design to help inform manufacturing changes.
Make use of appropriate technical skills and tools, such as DOE, SPC, hypothesis testing, capability studies, Gemba walks, and hands on analysis, to perform in depth analysis, determine root cause, and identify corrective actions.
Generate actionable ideas to reduce cost, cycle time and increase yield.
Ability to understand how to flow requirements from a top-level design down to a manufacturing process specification.
Must Have: Minimum Requirements
Bachelors degree in engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
Nice to Have
Experience with leading/executing process validation activities (installations qualifications, process characterization, operational and performance qualifications)
Experience interpreting mechanical drawings.
Experience with DFMEA and PFMEA
Experience with design of experiment (DOE) and other statistical methods.
Work experience with the following: FDA Quality System Regulations, current Good Manufacturing Practices (cGMP), ISO 13485, ISO 9001 standards or equivalent.
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