OQ IQ and PQ, Qualification testing of consumables for IVVD includes but not limited to critical to function test such as burst test, torque test, tensile test, pressure test, seal test and other propriety test. Tooling fixtures design and fabrication for Micro Vu Inspection and measurement.

Support Fatigue Testing Lab that utilizes my skills such as... writing test validation protocol and designing test for appropriate fatigue testing, gauge R&R, conceived and execute test with fixture design using Solid Works 2011. Fabrication of tooling and fixture using machine shop tools like drilling, milling and lathe.Support New Product development from Phase 0 to up phase 4. Test Method (TM) development such as Migration, balloon burst, Stent Graft tensile, spring tensile, joint force tensile and fatigue, Radial Fatigue Force (RDF) testing up to 400 Million cycles. Track and deploy on Zwick (Horizontal Tensile machine).

Supported Process Development (PD) for new product process.Optimization of the PeBax bonding using laser bonding.Tensile test bonding with the used of instron.Failure analysis of new product rejected catheter.Updated and created new procedures.Developed and wrote Manufacturing Process Instructions (MPI) for proximal marker..Created and performed OQ (Operational Qualification)/ PV (Process Verification) on IR laser proximal bonding, Proximal Hot stamping Marker and Swage Marker Band.Process Development for the Cryogen Balloon Ablation System. Processes such as inspection vision system, balloon vacuum/pressurized system, swaging process. Gage R&R, process capability, normality analysis and correlation studies on different parts of the Cryogen Balloon Ablation System. Performed Attribute & Variable Test Method validation using Boston Scientific Corporation guidelines. Software utilized for statistics was MiniTab 15 Statistical Software.

Supported new product development. Implemented document change requests.Wet and film lay-up with pre-pref honeycomb and other core for QC testing. Analytical weights and density measurementsApplies broad knowledge of QA concepts and practices.

Contributed original concepts to the development of catheter prototype and fixtures. Supported production for the vascular access and diagnostic product.Designed and fabricated new prototype fixtures and processes equipment.Independently developed reports and recorded scientific data. Fusion splice fiber optics..Performed evaluations, design of experiments, validations and IQ/OQ's.Build prototype for various product lines.Tested and evaluated adhesives and polyurethanes.Process development for metallurgy in polymer and failure analysis

Provided technician support to new transducer product and process development.Conducted prototype builds, helped developed new and improved processes including wet clean, plasma clean and surface priming processes for the transducer assembly.Categorized, organized, integrated and recordd data. Provided input to engineering, qualification and validation studies.Wrotes procedures.Wrote analysis report for implementation.Transferred products from R&D to manufacturing.Provided support in the manufacturing integration of new products to manufacturing.Transferred new product assembly technology from one plant to another.Used of Instron to test lap shear and peel test for material qualification.Wrote newly developed products' SOP and POP for laminations, bonding, dicing and lens casting.Reviewed and updated SOPs for manufacturing assembly processes.Conducted process validation of new processes.Working knowledge with QSR (Quality System Regulations) calibrations maintenance and scheduling.Responsibled for EO builds to support clinical trials for various products

Categorizes, organizes, integrates and records data. Provides input to engineering, qualification and validation studies. Writes procedures.Wrote analysis report for implementation. Transferred products from R&D to manufacturing. Provided support in the manufacturing integration of new products to manufacturing. Transferred new product assembly technology from one plant to another. Used of Instron to test lap shear and peel test for material qualification. Wrote newly developed products' SOP and POP for laminations, bonding, dicing and lens casting. Reviewed and updated SOPs for manufacturing assembly processes. Conducted process validation of new processes. Working knowledge with QSR (Quality System Regulations) calibrations maintenance and scheduling. Responsible for EO builds to support clinical trials for various products