Created and executed engineering changes to manufacturing equipment and manufacturing processes used to build medical devices.Created and executed IQ, OQ and PQ protocols, analyzed the results and wrote the final reports.Created operations procedures and improved existing procedures for setting up and running equipment, and performing manual processes used to build medical devices.Led a Total Productive Maintenance (TPM) team to improve the setup and operation of manufacturing equipment.Created maintenance procedures and improved existing procedures for equipment used to build medical devices.Trained others on 5S, TMP and Overall Equipment Efficiency (OEE).Completed Non Compliance investigations of manufacturing issues.Mentored technicians and less experienced engineers by guiding them through the quality systems, and manufacturing processes, and suggesting alternative solutions to problems.

Created and executed engineering changes to manufacturing equipment and manufacturing processes used to build implantable medical devices.Completed CAPA investigations of the validation of legacy processes and the calibration requirements of the process and measuring equipment. The results of the calibration investigation lead to improvements in the calibration requirements of the process and measuring equipment.Created and executed gauge R&R protocols and test method validations to determine if the gauges and test methods met the necessary requirements. Created and executed validation protocols to test processes used to build implantable medical devices. Analyzed the testing data, wrote technical reports and presented the results.Created operations procedures and improved existing procedures for manual processes used to build implantable medical devices. Created maintenance procedures and improved existing procedures for equipment used to build implantable medical devices. Completed Non Compliance investigations of manufacturing issues. Mentored technicians and less experienced engineers by guiding them through the quality systems, and manufacturing processes, and suggesting alternative solutions to problems.Supported the back room during internal and external audits. This included analyzing documents and providing the audit leads with the information needed to address audit questions.

Validating syringe filling operations at a contract manufacture.Designed improvements for pharmaceutical manufacturing equipment, laboratory equipment and syringe packaging components.Created and executed engineering changes on pharmaceutical manufacturing equipment and syringe packaging components.Compiled and maintained lists for cGMP equipment at all CMO sites and within the company.Wrote maintenance and operations procedures for pharmaceutical manufacturing equipment. Wrote and executed protocols to test pharmaceutical manufacturing equipment, laboratory equipment and syringe packaging components. Analyzed the testing data, wrote technical reports and presented the results.Performed laboratory testing of various syringe device componentsAssisted contract manufacturers with validation and manufacturing issue resolution.

Improved the manufacturing processes used to build catheters and biosresorbable stents.Wrote and executed protocols to test catheters and stents.Analyzed testing data.Wrote technical reports.Presented results and analysis of testing data.

Lead Process Engineer for the start up of a clinical sterile vial filling facility. This included the purchase, installation, startup and validation of several pieces of equipment.Responsible for the purchase, installation, startup and validation of three inspection systems that use a new technology. Total project budget of $1.5 million.Represented Genentech and made presentations at leading pharmaceutical conferences. Supervised two contract engineers and worked with a vendor in the US and Germany to rebuild equipment. The project was completed on time, under budget and met its objectives.Performed Right the First Time Engineering Design Reviews and Change Record assessments.Facilitated a Biweekly meeting to coordinate projects for manufacturing equipment. Led a Total Product Maintenance team to improve the setup and operation of manufacturing equipment.Completed company training on Operational Excellence for Team Leaders. This includes DMAIC, Lean, SPC, DOE and a project that optimized a vial washer process that reduced water usage by 40%. Led a Safety Improvement Team. The team determined the appropriate response to safety suggestions.

Responsible for long-term maintenance of equipment used in semiconductor wafer fabrication or computer chips manufacturing. This included writing capital justifications, and build and acceptance criteria. In addition, installed and brought the new machines online.Analyzed Statistical Process Control (SPC) charts and wrote Out of Control Action Plans (OCAP) that reduced machine downtime.Lead Engineer of a $25 million upgrade of a wafer fab facility. Coordinated the purchase, shipping, installation and startup of several systems.Wrote maintenance and departmental procedures.Created a spare parts inventory for the systems.Active member of several quality improvement teams. Managed the assets for the semiconductor fab as the assets were transferred or sold.

Responsible for long-term maintenance of equipment used in semiconductor wafer fabrication or computer chips manufacturing. This included writing capital justifications, and build and acceptance criteria. In addition, installed and brought the new machines online.Coordinated the purchase, shipping, installation and startup of several plasma etch systems.Organized and ran monthly Pareto Meetings to determine ongoing problems and their solutions. Wrote maintenance and departmental procedures.Created a spare parts inventory for the systems.Active member of several quality improvement teams.