LUKE A. BIXLER
********@*****.*** I 216-***-**** I LINKEDIN.COM/IN/LABIXLER
Cradle to grave product ownership Lean manufacturing/process optimisation ISO 9001 / 13485 QMS compliance CE, REACH, RoHS compliance Product testing Return goods evaluation
Manufacturing Support Customer Support
Developed procedures and practices to bring product line to ISO 9001 readiness
Increased operating efficiency of core company process resulting in $100,000 annual savings
Implemented SPC controls to plating process boosting efficiency from <80% to over 95%
Overhauled fiber product line with launch of new ERP system - increased accuracy of time and materials and generated >4000 part numbers and routings
Redesigned hardware and process for over $500/event savings and process gas recycling
Guided company through two maintenance audits for ISO and CE compliance
Implemented RoHS and REACH compliance for all products
Conducted PPAP and PFMEA review for customer regulatory compliancy
Designed and built testing fixture resulting in 50% time reduction and increased accuracy
Redesigned key product for 50% labour and materials savings
Managed team for new electro-mechanical device with a new client through product launch
Headed UL and CSA compliance for new products and facilitated quarterly audits Proficient in Solidworks, Creo, AutoCAD, Minitab, Microsoft Office, Access, VBA, machining, vacuum PRODUCT DEVELOPMENT AND MANUFACTURING ENGINEER
10 years experience in new product design, manufacturing, and quality management in electro-mechanical, medical gas, and radiation detection industries PROFESSIONAL EXPERIENCE
Saint-Gobain Crystals Hiram, OH, Oct. 2012 – Aug. 2015 Product Engineer, Gas Tube Radiation Detectors
Transitioned quickly from general engineering support to ownership of product line including NPD, customer support, and manufacturing support, process optimisation, and ISO implementation Bay Corporation Westlake, OH, June 2010 – Oct. 2012 QA / Product Engineer
Owned Quality Management System complaint to ISO 9001, ISO 13485, and CE marked medical devises, returned goods management, and CAPA as well as new product design and customer support Tecmark Corporation Mentor, OH, Nov. 2007 – June 2010 Mechanical Design Engineer
Contributed to new product development and legacy product support as well as manufacturing and customer support
EDUCATION
BSc, Mechanical Engineering, 2006 • Case Western Reserve University, Cleveland, OH TECHNOLOGY SKILLS