Edwin Lye

Experience

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  Abbott Vascular

  Mar 2004 - Oct 2013

  Initiated and closed work orders. Repaired various machinery and performed equipment qualifications.* Trained operators on catheter processes and engineering changes.* Modified, repaired and qualified to Equipment for the Endovascular Stent catheter process.Initiated tooling changes to reduce employee injury.Updated Lot History Records for building catheters improving process time by 20%.Prevented scrapping by 40% by revising drawings and tool refurbishment.Made minor adjustments at many operations improving ease of use and throughput, decreasing scrap by 5%.Generated Change Orders for new and/or improvements to documents, increasing throughput by 10%.Quality Technician – Abbott Vascular 2007 – 2012* New Product Development - Supported Characterization studies& First In Human by testing product and analyzing data.Certified Quality Control Inspectors and Assemblers to newly developed test methods.Worked with QC Inspectors to improve Standard Test Methods.* Assist engineers in developing methods to control and improve manufacturing process for Guidewires and Accessories.Provide technical assistance to engineering for manufacturing efforts by implementing corrective and preventive actions.Review and analyze data to determine manufacturing issues and trends for Guidewires and Accessories.Support process development team engineers by scheduling / overseeing product reliability testing.Cost Improvement Projects that realized over $1,000,000 in savings.Championed and initiated documentation for the implementation of Infinity QS reduced errors by 70%.Updated documentation for the implementation of eLHR errors reduced by 70%.Assisted engineering in providing manufacturing support by learning to analyze data and identify manufacturing issues and trends.Performed investigations (CAPA) related to product incidents, product nonconformance, and processing issues. Show less Directed team to work with and for production in order to meet daily goals with a high standard of quality.Assisted group members in problem solving, trouble shooting and handling of unique situations.Applied extensive knowledge of business concepts, procedures and practices and a complete understanding of fundamentals in a functional area, and working knowledge of other related disciplines.Review and disposition nonconforming material through the use of quality tools and by developing knowledge of manufacturing processes.* Performed reliability engineering testing for validations.Performed line clearance audits and product testing for production.Experienced in production and manufacturing support.Review and disposition nonconforming material (NCMR) through the use of quality tools and by developing knowledge of the manufacturing processes. Show less

  • Engineering Technician

    Mar 2004 - Oct 2013

  • Quality Control/Lead Inspector

    Mar 2004 - Jan 2007
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  Organogenesis Inc.

  Aug 2015 - Dec 2021

  Senior Manufacturing Technician
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  Bioserv Corporation

  Mar 2022 - Nov 2023

  Project Coordinator/Manufacturing Associate