OBJECTIVE

• Seeking a Quality/Manufacturing Engineering position

TECHNICAL SKILLS

• Agile
• Arena
• Windchill
• MES
• eCAPA
• SAP
• MRP
• Auto CAD
• 5S training
• ISO training
• Kanban

PROFISSIONAL EXPERIENCE

Confidential, Fremont CA

Quality Engineer

Responsibilities:

• Reviewed nonconforming material in production, approve the work instruction and approve for closure in MES NC
• Created/approve NCEP/CAPA for nonconforming material in eCAPA system and MES software
• Participate in the development of Failure Mode and Effects Analysis (pFMEA), apply to CAPA score and severity rating.
• Performed IQ, OQ and PQ on medical device capital equipment including MDU5, ILAB and Polaris
• Utilized effective problem solving techniques to define problems, determine root causes, develop and verify countermeasures on production line.
• Participate in equipment and process validation projects. Facilitate or execute the project plan
• Performed extensive statistical analysis of production lines to evaluate manufacturing processes and determine improvements.
• Work with third party suppliers and contractors to determine root cause and corrective actions and document findings and provide feedback

Confidential, Milpitas, CA

Quality/Manufacturing Engineer

Responsibilities:

• Created, reviewed, and updated Manufacturing Processes Instruction (MPI) for new and existing product.
• Utilized effective problem solving techniques to define problems, determine root causes, develop and verify countermeasures on production line.
• Participate in equipment and process validation projects. Facilitate or execute the project plan
• Performed extensive statistical analysis of production lines to evaluate manufacturing processes and determine improvements.
• Utilized Six Sigma methodologies to continuously improve manufacturing processes.
• Establish PCBA design guidelines for engineering team to improve DFM, DFT and DFX.
• Performed IQ, OQ and PQ on NPI and existing production as well as manufacturing equipment’s.
• Worked with quality and production to use the CAPA concept (Corrective Action Preventive Action) to improve processes to eliminate route cause.
• Worked with component engineer, material engineer and design engineer to approve new supplier, update and maintain the AVL.
• Attended daily and weekly meetings with Project Engineer, Design Engineer, Test Engineer and Quality Engineer to review project activities and drive completion of all manufacturing issues.
• Responsible for manufacturing process development of iris - related medical devices, including cornea
• Created and uploaded the corresponding documents, MPI and Source files into Agile, approve the incoming ECO, MCO and Deviation.
• Supported the production to set up test and manufacturing station and resolve any issues regarding to the assembly process and drive all manufacturing changes to improve quality, reduce the cost and improve the cycle time.
• Worked with CM companies to drive product introductions into their factory and improve quality, cost, lead time and manufacturability

Confidential, San Jose, CA

Quality/Manufacturing Engineer

Responsibilities:

• Lead manufacturing/quality engineering team to engage in line set up and cost analysis for different products
• Review incoming notification through Agile and Arena, generate ECO package, create, and customer document for accuracy and implement in SAP.
• Perform ISO 9001 internal audit from SMT machines and operation to make sure they operate per ISO standard.
• Perform IQ, OQ and PQ on NPI and existing production and manufacturing equipment’s.
• Restructure the box build BOM, separate sub assay and create individual package
• Create manufacturing process instruction (MPI) for PCB assembly, Box build and Clean room.
• Set up reflow and wave profile for leaded and RoHS products, work with production line to reduce the soldering defects.
• Work in clean room to optimize the process, reduce the non-value added steps to improve the quality and output.
• Review box build process and assembly method to improve performance, yield and reduce scrap.
• Identify and make recommendations to eliminate bottle-necks in the production line and increase the production capacity and identify major yield points to work on..
• Calculate labor quote and manpower for new and existing project for the PCBA and box build assembly.
• Set up daily and weekly quality meeting with QE, TE and customer to review QC and test data to improve quality, cost and delivery.
• Managed all the NPI phases, Proto type and pre-production at contract manufacturing site.
• Conduct technical investigation involving the application on a wide variety of component, verification and validation process
• Chair weekly quality meeting with customer and CFT members to review quality data for SMT, ICT and functional test data, create action items to improve yield
• Verified RoHS and Lead Free products create part number with prefix to implement BOM.
• Created BGA profile for various BGA's and review under Dage to verify BGA quality.
• Create Design For Manufacturability (DFM) and Design For Testability (DFT).
• Responsible for the transfer of the product from R&D into production.
• Work with customer to create engineer change request ECO and MCO
• Implement and review BOM, part details, on Arena and Agile.

Confidential, Mt View, CA

Manufacturing Engineer

Responsibilities:

• Set up the manufacturing process for medical devices and Ultrasound equipment; generate Bill of material for medical device equipment on UNIX and SAP data base.
• Worked with component engineer, material engineer and design engineer to approve new suppliers, update and maintain the AVL.
• Review PCB design for manufacturability (DFM), write engineering change request (ECR), engineering change order ECO, generate complete Bill Of Material using UNIX and SAP software.
• Configure BOM's/routings for PCBAs/ systems in accordance with the product structure and import them through the ECO into Agile/Oracle environment.
• Interface with contract manufacturing supplier on weekly and monthly basis to review ICT and FQC data and formulate the process improvement plan.
• Worked with quality and production to use the CAPA concept (Corrective Action Preventive Action) to improve processes to eliminate route cause
• Tracking daily MRB listing for disposition and perform solderability. Baking and failure analysis as needed.
• Support production line for tooling and fixturing, process improvement and outsourcing and support to achieve their shipment and cost.
• Work with component engineer, material engineer and supplier engineer to approve new suppliers, update and maintain the AVL.
• Review and update fab and assembly drawing in Auto CAD.

Confidential, San Jose CA

Project Engineer

Responsibilities:

• Create manufacturing process instruction (MPI) for PCB assembly, rework instruction and Box build.
• Work with Quality Engineer, test Engineer to create quality data and review for accuracy to improve the process and increase the yield.
• Created BGA profile for various BGA's and review under Dage to verify BGA quality.
• Review customer drawing and Gerber File on G.C Place.
• Configure BOM's/routings for PCBAs/ systems in accordance with the product structure and import them through the ECO into Agile/Oracle environment.
• Create Design For Manufacturability (DFM) and Design For Testability (DFT).
• Support production line for tooling and fixturing, process improvement and to reduce the cost on time delivery
• Conduct technical investigation involving on variety component, verification and validation process.
• Responsible for Corrective Action Request (CAR), Return Material Authorization System (RMA) and Material Review Boards (MRB).
• Set up quality meeting with customer and CFT members to review quality data for SMT, ICT and functional test data, create action items to improve yield
• Coordinate Failure Mode Effect Analysis (FMEA) on rejected board at ICT and Functional test.
• Set up the SMT manufacturing process for lead free (RoHS product and set up rework process and profiling for BGA and ICs.
• Drive continuous process improvement efforts to improve product quality, yield, productivity and cost.
• Investigate on PCB related problems and identified the root - cause and proposed internal and external corrective action to resolve the problem.
• Set up the daily and weekly quality meeting with project engineer, process engineer, Quality engineer test engineers and production supervisors to review the QC and test data.

Confidential, Fremont CA

Process Engineer

Responsibilities:

• Hands on experience with through hole, SMT parts, PCBA final assembly of complex unites in high volume high mix and high volume low mix operation.
• Defining process layout, and equipment needed to meet production needs, developing and maintaining process control
• Transitioning new products into manufacturing & review of design for manufacturability (DFM).
• Set up process for PCB manufacturing and testing in high volume environment.
• Implemented the SMT, PTH Process for RMA, OA and No Clean.
• Establish and design format for label standards and set up process control for production.
• Set up training for new engineer and tech support for printing, reflow and wave.
• Set up the BGA assembly and rework station.
• Set up a goal with other engineer for process improvement, new equipment evaluation and new process development.
• Responsible for stencil design, reflow and wave solder profile.
• Restructure the box build BOM, separate sub assay and create individual package
• Create manufacturing process instruction (MPI) for PCB assembly, Box build and Clean room.
• Set up reflow and wave profile for leaded and RoHS products, work with production line to reduce the soldering defects.
• Work in clean room to optimize the process, reduce the nonvalue added steps to improve the quality and output.
• Set up the Box build line through Lean manufacturing such as Kanban, Variation reduction to improve process flow.