Fort Wayne, Indiana, United States
•Authored comprehensive Work Instructions for Starrett Automated CNC program creation and validation. •Analyzed ISO Standards used during previous verification and validation testing to identify potential compliance gaps with current standards. •Drafted Drawings of new OEM Transfer project of Class II medical devices. •Executed lifecycle verification testing for laser etched GTIN data matrix, silicone brackets and silkscreen graphics.
•Designed custom fixturing for machining a new plastic component, projected to generate $400,000 in annual revenue. •Developed a go/no go gauge for quick on floor inspection and validated it through Gauge R&R analysis. •Implemented an efficient deburring process for machined plastic components and authored the associated Manufacturing Procedure. •Established quality standards for a plastic deburring operation in collaboration with a customer. •Optimized floor space and equipment ergonomics to accommodate new production equipment. •Reengineered a pass/fail gauge to detect recurring manufacturing inconsistencies at the source, reducing mass quarantines •Authored and executed IQ protocols and reports for new and relocated equipment. •Enhanced manufacturing procedures for greater uniformity and clarity. •Conducted a line characterization study to assess the impact of each manufacturing operation. •Analyzed tolerance stacking to determine space availability between inner and outer tubes of an endoscope. •Participated in a recall inspection of nonconforming product. •Utilized CMM, Starrett CNC, and Jenoptik devices for engineering study measurements.