Geoffrey Gaw Email & Phone Number

Irvine, California, United States

Santa Ana, California, United States

• Grew the team from 11 Engineers to 21 Engineers within the first eight months. • Dual roled as Functional & Program Manager for the last five months.• Drove functional excellence in process development including process characterization and transfer to commercial manufacturing for the following programs: Ellipsys (AV Fistula Creating Device), Capere (Mechanical Thrombectomy) and Concerto Versa (Peripheral Embolization)• Led and supported talent within the team by developing the technical capabilities, project management skills and overall skill sets of the team to ensure the on-going and future strategic business needs are met.• Drove technical rigor in technology development that aligns with the future operations strategy for the business and network stakeholders.• Collaborated with Core Team representatives to ensure that Operations’ needs and targets are incorporated into process development plans and activities. Worked with Program Managers on higher priority programs for the business.• Collaborated with Operation to ensure a smooth transition of new processes from pilot environment to commercial.• Partnered with R&D to align group skills and capabilities with NPD strategies and future process technology needs.

Rancho Santa Margarita, California, United States

• Led and Managed 2 Teams: 1 Product Team (Open Fusion Energy Device) and 1 Manufacturing Team (Metal Process Development), consisted of 32 Engineers.• Designed and developed in-house top level assemblies, sub-assemblies and components manufactured by the following: metal injection molding, injection and insert molding, vertical milling, stamping, laser welding and semi-automated assemblies.• Oversaw following manufacturing processes and associated equipment: stamping, wire forming (spring making), punching, swiss screw machining, wireEDM, laser welding, laser cutting, tumbling and passivation.• Strategized future expansion and growth of Products and Manufacturing Areas with cross functional teams. Provide capacity and financial analysis/metrics to support proposals.• Led the development of equipment, fixtures and tooling from the design phase to the implementation phase.• Identified opportunities and proposing solutions to improve production yields, manufacturing capacity, cost reduction and product quality.• Led several projects that resulted in doubling manufacturing throughput of top level devices and improved the manufacturing throughput of several critical components as much as eight folds.

Rancho Santa Margarita, Ca

• Led a team of Engineers in developing and sustaining the following manufacturing processes for the Open Fusion Energy Device (Gen 1): injection molding, metal injection molding, insert molding, extrusion, advance metal processing, stamping, laser and tack welding, manual and semi-automated assemblies.• Identified opportunities and proposing solutions to improve production yields, manufacturing capacity, cost reduction, and product quality.• Led and reviewed non-conformance investigative reports (NCIR) and corrective and preventative actions (CAPA) activities to ensure continuous production with high quality.• Reviewed and developed Design Validation/Verification plans, protocols, reports and managed risk management activities for a class II medical device.• Reviewed and developed Process Validation/Verification plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ).• Worked effectively with cross-functional teams to ensure the project deliverables were complete and accurate.• Reviewed and developed manufacturing instructions/procedures, test methods and test method validations to ensure process stability and appropriate AQL Sampling.• Led the development of equipment, fixtures and tooling from the design phase to the implementation phase.• Led the improvement of several components and sub-assemblies from poor yields to 95%.• Led the improvement of the Open Fusion Energy Device from poor yields to 95%.

Rancho Santa Margarita, Ca

• Developed and sustained the following manufacturing processes for the 5mm Trocar (Gen 4), 5mm Fusion Energy Device (Gen 1), and Open Fusion Energy Device (Gen 1): injection molding, metal injection molding, insert molding, extrusion, advance metal processing, stamping, laser and tack welding, manual and semi-automated and automated assemblies.• Efficiently wrote non-conformance investigative reports (NCIR), test protocols, reports, test methods, and manufacturing instructions/procedures. • Collected and analyzed data and trends to develop, evaluate, and validate manufacturing processes.• Developed Design Validation/Verification plans, protocols, reports and managed risk management activities for class II medical devices.• Developed Process Validation/Verification plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ).• Developed and designed equipment, fixtures and tooling from the design phase to the implementation phase.• Brought in-house multiple critical components/processes from design phase to production phase.

Covina, California, United States

Prototyped and designed load cells per customer requirements, provided new tooling and testing fixtures for load cell assemblies, worked with the production floor in order to optimize manufacturing, and created necessary manufacturing documentation for the production floor.Sustained current vibration measuring devices, provided R&D to improve vibration measuring devices, and provided new products in the vibration measuring industry.

Pomona, Ca

Tutoring Mechanical Engineering, Mathematics, Biology, Chemistry, and Physics.