MANAGER, QUALITY ENGINEERING Executive Summary With 14 years experience fields Class II III medical device manufacturing, molecular diagnostics, biotechnology; last 8 managing engineers, technicians well supervisors, I bring strong technical leadership organization. I solid background data analysis statistics I use develop continuously improve aspects manufacturing process focus efficiency consistency. Core Qualifications ProEngineer/CREO, MiniTab, MS Office Suite, MS Project, MS Visio, Injection Molding, Trackwise, Catsweb Professional Experience Manager, Quality Engineering April 2014 Current Company Name － City State Manage Quality Engineering Team, Complaints Department, Metrology Department Alcon's Class II Class III medical device manufacturing facility. Responsible improving site compliance reducing recurring deviations NCR Investigations CAPA implementation. Investigate customer complaints interface regulatory groups provide feedback doctors. Direct teams provide Calibration support two medical device-manufacturing facilities. Responsible setting priorities, providing direction, coaching, motivation, mentoring development exempt non-exempt direct reports. Senior Engineer II (Managed Process Engineering Automation Groups) March 2011 April 2014 Company Name － City State Process Control Lead Responsibilities added September 2013. Managed Process Engineering Automation Groups Alcon's Class II/III surgically implantable optic device delivery systems manufacturing facility. Responsible setting priorities, providing direction, coaching, motivation, mentoring development exempt non-exempt direct reports. Responsible engineering activities support related aspects manufacturing process including: Injection Molding, Assembly, Curing, CNC machining, Chemical Processing, Inspection. Applied technical expertise improve yield AcrySof® manufacturing. Helped reduce particulate reject rate Wavefront product 50%. Reduced dimensional failures 5% <0.3% and="" saved="" the="" facility="" ~$1.4m="" in="" labor="" and="" materials=""> Led implementation multiple automation projects, improved quality, increased capacity, reduced cycle time paybacks realized 1 3 years. Managed departmental budget, automation budget well capital projects achieve savings least $100k without sacrificing service levels. Senior Engineer I September 2007 March 2011 Company Name － City State Supervised Drafting group, Custom Tool Production, Milling, Injection Molding, Clean Room Engineering Support staff Class II Class III medical device manufacturing. Set priorities, provided direction, supervision direct reports. Specified, developed, procured, validated addition vision inspection systems automated milling machines improved cut quality consistency AcrySof® Single-Piece IOLs. Provided technical support injection molding process, assembly, curing, machining, clean room operations. Process Engineer II February 2005 September 2007 Company Name － City State Engineer responsible process development improvement Alcon's Class II/III medical device manufacturing site. Designed, built, validated, implemented next generation automated milling machines use AcrySof Single-Piece IOL manufacturing. Increased output AcrySof Single-Piece IOL milling 25% impacting quality iterative process adjusting key parameters verifying impact cycle time product quality. Designed, built, tested, validated prototype packaging labeling workstation. Evaluated prototype ergonomics work flow help production personnel. Modified design accordingly built, validating remaining 23 workstations. Validated improvements software initial release. The resultant stations prevent packaging failures getting field. Developed analyzed proof concept models evaluate manufacturing improvements using Pro/E prior implementation. Set priorities, provided direction, supervision one direct report Research Engineer September 2003 February 2005 Company Name － City State Designed, built, tested automated reagent packaging system improve lot homogeneity increase manufacturing throughput Lab-in-a-tube (LIATTM) technology. Created original Labview programs amended existing programs improve functionality numerous test fixtures automated systems. Designed built novel spotting-device producing protein microarrays compatible 96-well microplate format high throughput applications. Programmed Labview spotting routine protein microarray spotting-device. Tested numerous concepts develop design parameters LIAT analyzer (ie.tube tensioning, segment length, tube diameter). Assisted preparation patent applications responses examiner's actions. Patent Examiner July 2002 September 2003 Company Name － City State Reviewed patent applications compliance United States Code determined novelty invention. Composed reviews applications communicated applicants assist patent process. Graduate Research Assistant September 2000 July 2002 Company Name － City State Designed, built, tested apparatus producing sol-gel based DNA hybridization arrays. Developed troubleshot instrumentation controlling pad size placement within array. Developed sol-gel production protocol provide specific pore size flow characteristics use capillary chromatography. Created aerogel samples, conducted compression testing, measured internal surface area. Education Master Science Mechanical Engineering UNIVERSITY OF VIRGINIA － City State Bachelor Arts Physics Biology COLBY COLLEGE － City State Skills Manufacturing, Assembly, Automation, Budget, Calibration, CNC, Coaching, MS Office Suite, MS Project, MS VIsio, MiniTab, Stat Graphics, Process Engineering, Manufacturing process development improvement, Manufacturing yield improvement, CIP, Pro Engineer/CREO Awards Memberships Alcon Special Achievement Award Graduated distinction Physics Member Sigma Pi Sigma, Physics student honor society