•Successfully led Process Validation activities for Stent Graft System and PQ Crossing device for US FDA Class III premarket application. Functioned as Technical ME lead and Project Manager to drive timeline.•Author of Master Validation Plans, equipment and software validations, process OQ/PQ Qualifications. Improved manufacturing documentation (DMR, MPI, QPI, LHR, TRVs)•Performed time studies on both devices’ assembly process, improving PQ Crossing process throughput by 300% and Stent Graft process by 40%.•Effectively improved UV bonding process on subassemblies and final assembly lines by fixturing UV curing workstations, implementing better UV curing adhesives and performing process development through DOE/confirmation runs. •Yield Improvement. Performed root cause analysis to eliminate PTFE delamination on Catheter Shaft processes and bring yield performance up to a 98%.•Supported improvements on Stent frame supplier process by identifying key factors impacting their laser welding capability to consistently meet weld strength requirements and cosmetic quality attributes.•Successfully supported manufacturing activities to build devices for two Clinical trials (Detour and Torus trials), following Investigational device exemption (IDE) regulations in order to meet company milestones and goals.

Principal Manufacturing Engineer at Abbott Vascular - Structural Heart (E-Valve) improving manufacturability of the Mitra Clip device.- New Product Introduction. Provide DFM to early New Product design, New Design and process characterization. Perform new product performance test and analyzes test data using JMP, Minitab and recommend component design improvement to R&D team.- Work in cross function project team to build and test new product, study new product performance characteristics, determine areas of design and process improvement for new component, materials, and process improvements.- Responsible for setting up and maintain Pilot assembly line to support new product development builds. - Procurement and characterization of new capital equipment.- Design Control, Execution of Design Verification, Filing and Aging Validations. Write and execute Process Validation Protocols and Reports.- Execution of Process improvement and CAPA projects using DMAIC, MS Projects, ProChain -Mfg Equipment and Production fixtures design,procurement and implementation.-Development of new assembly processes, equipment selection, fixture design to support new product design validation and implementation.-Experience promoting the use of Statistical Process Controls (e.g., A3, DMAIC, DOE, SPC) and continuous improvement techniques in manufacturing and at suppliers to help reduce variability and achieve process control. - Works with R&D and QA to improve manufacturing processes, component design, inspection methods and PFMEA documentation.- Vast Experience on catheter manufacturing equipment such as heat bonding, Vertical shrinker, RF bonder, UV and Light cure equipment, Surface treatment, Centerless grinding, Hydrophilic Coating, Pouch sealing, Mechanical assembly custom equipment.

- Provide manufacturing engineering support on day to day basis to the Proglide, Prostar, Xceed and the Star Close production assembly areas.- Identification and development of CIP projects on the manufacturing process and inspection activities (Lot acceptance, Savings of $542K Yr).- Development of manufacturing processes using six sigma methodology (DMAIC) to improve process capability, development of yield improvement projects, resulting in Final assembly scrap reduction 30%- Use of DMAIC for root cause analysis during functional failures.- Mentoring peers on the use of six sigma methodology on the development of improvement projects for the Operations review meetings.- Successfully performed the RWC cleanroom time studies to understand the production area work force required to meet production demand, bottle necks identification and improvements leading to line capacity increase and production efficiencies.- Development of production area efficiency projects/metrics to continually reduce waste on assembly area and improve UPPH.- Established the RWC products manufacturing scrap rate for the 2010 standard cost model.- Lead the ME group to provide support to self-expandable stent production area.- PTT activities (Product Technology Transfer) between R&D and Manufacturing. Reinforcing that transfer of design control activities to the operations environment is capable of sustaining the quality of product and the manufacturing line efficiency.- Lead Design Input/ Design Select / Design Transfer Manufacturing Plans and interaction with R&D / Purchasing / Validation / QA departments.- SME in Production assembly equipment and assembly line performance.- Execute yield improvement project, 5s, continuous production waste reduction.- Study and improvement of functional failure observed during lot acceptance activities.- Documentation and Improvement of NCR / Exemption activities.

- Process Improvement Site Group Leader, managing and executing Cost Improvement Projects as Black Belt, communicator and coach of Six Sigma and Lean methodologies and philosophies, mentoring of LSS projects. - Established Six Sigma and Lean Mfg Program with Green Belt training at Abbott Redwood City site.- Identify opportunities for Lean Mfg and Six Sigma improvement projects and created a pool of project driven by PMO.- Successfully assessed, developed and executed a strategy for StarClose to reach and maintain 1000 units / Shift or 2000 units / day, time studies completed, line layout improved, line capacity was improved from 650 units/Shift to 4000 units/day - Project Benefits - Supported StarClose scale up for US launch ($ 4MM above WW Plan in first quarter)- Leader on the development of the LSS project for Star Close vessel closure device to improve line efficiency. The assembly line efficiency was improved to double its production capacity after USA launch. Annual savings of $2.7 million dollars in 2007. - Performed as manufacturing engineer on the design of an automated assembly line for the Star Close product, reducing operator dependency on the assembly process, equipment was design to meet a cycle time that allowed the reduction of direct labor from 35 to 21 operators exceeding the manual line capacity.- Improvement of different assembly lines and integration of packaging areas, resulting on a 1 week reduction of production cycle time.- Successfully influenced the Fox Plus group (Beringen, Switzerland) in the implementation of continuous flow manufacturing processes to achieve their production goal.- Eliminated dependencies of multiple assembly lines and packaging area, reducing overall manufacturing cycle time by 5 days. -Successfully execute Kaizen events to improve production and Receiving inspection areas.- Lead a group of 4 engineers and 2 technicians as direct reports.

-Lead the production team in a 56% ramp-up activity for the AAA catheter, involving the development of time studies, target areas of opportunities in the product design and production line layout improvements.-Improve TAG catheter manufacturing line. New equipment was purchased to retool the existing production line increasing the equipment line reliability, reduction of operator variability and increasing production line capacity by 400%.

• Leader of Six Sigma Business improvement group, weekly meeting to track PE projects savings, PE Projects presentation, review of resources training records, development of site procedures to develop PE projects .• Identification and generation of improvement opportunities among three different Business units to achieve the company savings goal. • Instructing and tutoring of BB six sigma materials to colleagues.• Development of Six sigma Black belt projects to improve production area functional problems, scrap reduction.• Development of Lean manufacturing projects integrating assembly areas into one piece flow increasing line efficiencies by 80% in average.