Poway, California, United States
Mechanical Engineer (Project/ Process/ Design), Project Management, New product design and implementation to production, Manufacturing Manager Specialties: FDA Regulated Process Improvement, Capital Projects, cGMP Manufacturing. FEA, Solidworks, QAD, Pilgrim, Master Control, JMP
Responsible for pilot line development, manufacturing scale up, vendor/CM management, FDA regulated manufacturing support, manufacturing process development and transfer to Operations, large capital improvements and cost savings initiatives in the medical device industry. • NPI of G7 CGM device – Operations SME for Wearable Component Custom MFG Equipment o Development Line, Operations Lead Role for Wearable Component Integrated with R&D teams to provide Product and Process support to ensure scalable design for automation. Implemented semi-automated equipment on Pilot Line, including highly complex operations as Proof of Principal for full automation equipment and support of Process Development. o 4sec/Part Manufacturing Lines, Technical Lead for Wearable Component Equipment. CTL for initial 5 Lines Led design and implementation of complex automation equipment through multiple external vendors. Managed, design, build and implementation of MFG Lines through highly aggressive timelines. Led design of component packaging, including tape and reel which had not been previously implemented at Dexcom. Supported Quality System development, Software Validation, IT infrastructure, Facility infrastructure, Process Validation and Process Development for Automation. Led Technical Team through many requalifications due to software and mechanical updates throughout the lifecycle of the project. o 2sec/Part Manufacturing Lines, Technical Lead for Wearable Component Equipment. CTL for initial 3 Lines (currently installed, qualification in progress). • NPI of G6 injection molded CGM Wearable device – Operations Core Technical Lead o Integrated with R&D teams and guided for process definition, development and requirement generation. o Led semi-automated equipment design and implementation for core process equipment.
• Automation equipment design and implementation
Process Engineer 2010 to Current MFG Site Validation Technical Lead • Worked directly with FDA Inspectors to obtain CA State License to Manufacture at Carlsbad Facility (APR2011). • Led Manufacturing Lab setup, Equipment Qualification, Facility and Process Validation. • Authored documentation for Equipment, Facilities, Process SOP, MDR, Process Validation. New Platform Development • New Manufacturing Process Development including Equipment Specification and Design for core company technology. • Managed design and build of custom high volume equipment through external vendors with integrated automation. • Developed Proof of Principal testing, URS, FAT/SAT protocol creation and execution, IOPQ, and Characterization of Process. Cartridge MFG Supervisor 2010 to Nov, 2013 Led Manufacturing Team in cGMP environment Medical Device. • Produced 4 IVD products and 4 RUO products • Dramatically scaled manufacturing capabilities; developed and led 3 MFG teams with 25 direct reports.
Responsible for product material and process cost savings efforts, ongoing design and manufacturing support, and productivity improvement projects. Led the research, test, and implementation of new packaging equipment and processes to yield a 15% improvement on product recovery rate in the Orange, France facility. Drove cost savings plan to rework downstream production processes, eliminating labor through higher automation, and lowering overall production costs.
Responsible for ongoing production support, managing equipment installation, leading new production line start-ups and driving productivity improvements. Designed and installed high volume packaging equipment on five new production line start-ups as well as on existing production lines.
Performed dynamic human gait analysis utilizing force plate and high-speed camera technology. Used load and position data to model human gait that was used to assess benefits of lower limb surgeries.