Gary Lu Email & Phone Number

Brea, Ca, Us

California, United States

- Collaborate with other product development and cross-functional teams to identify and implement design optimization projects including cost reduction, quality improvement, enhancement through design upgrades, assembly design, and sustainable design.- Provide conceptual, preliminary cost and quality estimates, analysis and evaluation plans to align with overall project schedule.- Perform cost-benefit analyses and finalize annual savings for specific projects.- Performs design trade-off analysis for multiple concepts. Generate sketches and other information necessary to create production drawings/specifications. Collaborate with designers to produce/approve drawings.- Modularize mechanical systems for efficient manufacturability, assembly, and ease of maintenance.Services.- Incorporate appropriate specifications for system level/subsystem performance and component performance into designs impacted by new projects.Incorporate appropriate specifications for system-level/subsystem performance and component performance into designs affected by new projects. Perform or update FMEAs on designs.- Drive the development and use of computer-aided engineering tools to optimize designs prior to prototyping and evaluation to shorten project cycles and reduce costs.- Develop and execute test plans to verify system performance using reliability design tools and performance sensitivity analysis.- Directs the development of prototypes for component and system testing. Directs the laboratoryMentor lab technicians throughout the model development and evaluation process.- Collaborate with manufacturing engineers to formulate the impact of development projects on labor costs and smooth introduction into production through pre-testing/pilot production.- Work with Regulatory Affairs team to obtain required product approvals and European product approvals.- Identify cost reduction opportunities by spend - Pareto analysis, accrued costs, competitor benchmarking and unbundling.

- Managed all aspects of nonconformity investigation (Incoming and Manufacturing), product disposition, management reporting.- Managed all product, process and Quality System nonconformance programs.- Managed and supported all anomaly, NCR, and CAPA activities and ensured that timelines were being maintained from initiation to closure.- Managed the NCP data logs; performed historical data searches, review and reports.- Generated both weekly and quarterly Management Review Board’s NCP Reporting.- Reviewed Quality System Document Changes and made correction recommendations.- management of team responsible for processing complaint files globally from Intake status to closure; including coding for USA, EU, China, Japan, Latin America, Australia.- Managed the creation, investigation and reporting of Medical Device Reports for submission to FDA if incident meets reportable criteria for bothMalfunction and Serious Injury.- ETQ Reliance system design for CAPA, Complaint Handling, Nonconformance, and Product Disposition.

I participate as a Senior Mechanical Engineer in Camera and Detector product development projects within the Thermofisher Image Acquisition and Detector program. These projects are executed with partners and focused on one of our product platforms. Within a multidisciplinary team I am responsible for: - Creating concepts and execute technical feasibility studies- Mechanical design and test reports- Release of new products- Sustainment of existing hardware- knowledge transfer to operations department- Team guidance and coaching of 4 to 6 mechanical engineers

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