Medical Device

2/2007 - /2008

Pfizer / Sykes

Individual Contributor

• Senior Business Consultant (R&D Instrument Compliance) – Pfizer, Contracted through Sykes Enterprises Inc. * Developed and maintained cGMP programs for repair, calibration, and preventative maintenance of medical equipment used in pharmaceutical research and development applications (i.e. OEM/Vendor - Agilent, Baxter, Beckman, Biotek, Fisher, GE, Harris, Hamilton, HP, Mettler, Millipore, Rainin, Revco, Tecan, Thermo, VWR, Waters, Zeiss). * Created technical documentation and interfaced with R&D, Scientific Base, and other subject matter experts. Also developed procedures and work instruction utilizing GDMS Documentum System for controlled documentation. * Applied Kaizen blitz techniques and 5s to eliminated bottlenecks and dramatically improved work flow for about 400 instruments processed monthly. Also developed dashboard reporting tools and program communications to properly track and administrate quality initiatives. These programs insured lab instrumentation followed FDA regulations in a well documented and traceable process.

1/2006 - /2006

Access Point Medical

Director / VP

• • ACCESS POINT MEDICAL, LLC. - St. Louis, MO. (Office closed) Jan 2006 – Dec 2006 Access Point Medical is a start up manufacturer and distributor of home care Durable Medical Equipment (DME). Director, Technical Services – Access Point Medical (4 Direct Reports, $300,000 P/L Budget) Recruited by Vice President of Marketing & Product Innovation * Held leadership responsibility for service & support operations and quality engineering. This included acquiring and converting a 30,000 sq ft warehouse/office facility into a complete start up service and support center for over 100 medical products. Hired direct reports and established a professional organization with technical phone support, product support lab, depot repair, parts inventory, shipping/receiving, and quality engineering. * Created product-modification deployment plans containing strategy, goals, logistics, budget, people resources, technical product detail, fixture construction, engineering change order, assembly line layout, validation, and authorization/release of product. Organized and directed manufacturing rework projects at local and remote locations. These programs increased profit margin 20% and achieved customer satisfaction by eliminating back-orders. * Developed trending codes and reporting to analyze product complaints per line item. Created and tracked corrective action (CAPA) to resolve product issues and comply with FDA requirements. * Conducted ISO 9000:13485 auditing and failure investigations with risk assessments that have reduced expense and company liability. Also conducted Failure Mode Effect Analysis (FMEA) on return products and used data to improve new product development as well as continuous process improvement for existing products. * Reduced spare parts expense by 76% through use of Finished Goods and RMA salvage programs. Also developed tool-less field repair through an innovative Repair Exchange Program and eliminated $50K in labor expense. * Evaluated new products/suppliers and validated engineering product change, pre and post manufacturing transfer.

12/1989 - 12/2006

Bausch & Lomb

Manager

• • BAUSCH & LOMB INC. - St. Louis, MO. (formerly Storz Instrument Co., held 7 positions) Jan 1989 – Jan 2006 Bausch & Lomb and Storz Instruments are medical device manufacturers that service and support state of the art ophthalmic microsurgical and refractive equipment. Bausch & Lomb is a $2.3B company that acquired Storz in 1998. Installed Base Program Manager (Installed Base Quality) – Bausch & Lomb Inc. (2 Direct Reports, ~ $5M Project Budgets) * Created service deployment plans for product change and new product launch. These projects included all logistics surrounding revision change of hardware, software, and new product launch. Details included strategic planning, time lines, due dates, schedules, territory responsibilities, training, installation, parts distribution, technical documentation, security, installed base tracking, modifications, testing, and validation. These programs assured service readiness. * Collaborated with R&D and D&D to create a Product Development Management Process (PDMP) that standardized Product Service infrastructure to accommodate service and support of new product introduction and revision change. * Developed operational procedures to track critical configuration aspects of the installed base and coordinated with appropriate departments. * Organized programs in response to product recalls, FDA violations (483), and field corrective action. * Represented and led auditing for product support quality ISO13485 compliance. Supervisor, Technical Support (Global Product Services) – Bausch & Lomb Inc. (10 Direct Reports, 37 Indirect Reports, $1.2M Budget) * Provided service support leadership for department staff (Field Service, Call Center, Engineers, and Admin). * Participated in design review meetings to provided technical service expertise for new product development. * Teamed up with Engineering and visited supplier sites of new technology to evaluate products and operations. * Participated in monthly quality meetings and led cross functional weekly meetings to reduce product complaints. Senior Technical Support Specialist (Global Technical Services) – Storz Instrument Co. * Participated in clinical Field Observation Study (FOS) design validation programs and investigated design failures. * Translated Voice of Customer (VOC) into measurable requirements to achieve design change and validation. * Responsible for competitive product evaluations, Failure Mode Effect Analysis (FMEA), & engineering projects. * Created training curriculums and instructed in Australia, China, Germany, Japan, Singapore, and the US. Technical Support Specialist (Technical Services) – Storz Instrument Co. * Provided technical phone support, troubleshooting, and parts diagnosis to users of sophisticated instrumentation. * Transferred engineering knowledge and specifications into training programs, user instruction, and manuals. * Tested and evaluated engineering prototype products during development stages. * Developed new product software requirements and conducted validation testing. Senior Service Technician (Diagnostic Service Center) – Storz Instrument Co. * Provided tier 3 (top level) field services when normal repair technicians were unable to resolve field issues. * Created corporate policies, procedures, and technical bulletins within ISO 13485, and 21CFR standards. * Used Kaizen to reduced turnaround time 20% by eliminating non-value added activity and reorganizing flow process. Product Service Technician (Diagnostic Service Center) – Storz Instrument Co. * Field and depot repair, calibration, installation, and preventative maintenance of medical devices. * Eliminated over $94,000 of annual expense caused by improper use of equipment. * Consultant for medical device manufacturing and production rework. Associate Service Technician (Equipment Repair) – Storz Instrument Co. * Repaired electronic, fiber optic, hydraulic, laser, optical, mechanical, pneumatic, and ultrasound medical devices. * Achieved top-level quality control acceptance status (includes ISO9001 Compliance).

2003

Bachelor Degree

National Louis University

• Business & Management

1987

Associate Degree

St Louis Community College

• Electronic Engineering Technology