Responsible for overseeing the development, implementation and sustaining of efficient and scalable manufacturing processes that delivers quality products.

sible for Planning, Manufacturing, Warehouse, Distribution and FDA Compliance.Develop Processes, Tools and Fixtures with Manufacturing Engineers that will Improve Product manufacturing and Production Efficiency.Analyze Yields, Productivity and Delivery Metrics to Locate Areas for ImprovementsWork Closely with R&D Managers and Quality Manager to Ensure Production Issues and New Products and Manufacturing Plans, Using SPC, DOE, PFMEA and Design History File (DHR).

Responsible for transferring products from project to commercializing.Make division’s Strategy, objectives, plans, goalsWork on major complaints related to MDM. Work on problem solving techniquesUsed the greenbelt to reduce the cycle time.Analyze Yields, Productivity And Delivery Metrics To Locate Areas For ImprovementsWork Closely With Project Manager And Quality Manager To Ensure Production Issues And New Products Are Taken Care Of Promptly And Mitigate Any Effects On The Production Plans

Sr. Manager, Processing Engineering ISBEngage in new product development throughout the NPI process to assure manufacturability and testability Establish Daily measurement and Analyze correct actions to improve the safety, quality and productivity.Ensure correct resourcing and process management to support and in somecases lead customer DFM and VALVE programs to maintain and capture new business.Lead implementation of lean - six sigma manufacturing projects(CPI, with objective of process, tooling, PM improvement program by ME team Total savings $800k.Establish validation master plan for the cleanroom and processes (IQ,OQ, PQ)

Diagnostic focused on products that analyze particles and living cell forms, structures, or morphology in both urine and a variety of body fluids. Our product portfolio leverages our strengths in flow imaging technology, particle recognition software algorithms and integrated automation to bring productivity, quality, and standardization to the laboratory environment, where labor-intensive processes result in significant cost and workflow challenges for our customers.Responsible for driving process improvement through the use of Six Sigma/Lean tools and methodology. Lead 7 Kaizen Event in one year.Establish Daily measurement and Analyze correct actions to improve the safety, quality and productivity. lead implementation of lean - six sigma manufacturing projects(CPI, with objective of process, tooling, PM improvement program by ME team Total savings $900k.

Primary Deliverable: Visio Process Map(s), Description and gap identificationProcedure mapping with R&R assessment and Gap analysisAn excel file that shows the procedure trees. From the top level procedures show all children procedures either explicitly referenced or identified within the procedure body. For each procedure identify the functional owner and weather the procedure identifies Roles and Responsibilities (R&R).Desk assessment of compliance to CFR 820.50 and ISO13485 to be specified corporate policy elements Integration of assessment of compliance to the procedures based on the “as is” process mapping. Establish supplier management program to maintain supplier files, supplier Evaluation and Reevaluation, Identifies and Implements supplier quality improvement initiatives, and manages Supplier Corrective Action Requests (SCAR).Responsible for driving process improvement through the use of Lean tools and methodology total savings $900,000/year in PPV.

Manage 100 assemblers, maintenance, planning, purchasing and process engineering in the operation of Transcatheter Heat Valves.Generate daily production plans based on projected customer demand and issue materials required to meet plansSet production goals based on plans and ensure completion by coordinating resourcesWork within budgetary and time constraints to ensure production plans are metDevelop processes with manufacturing engineers that will improve product manufacturability and production efficiencyAnalyze yields, productivity and delivery metrics to locate areas for improvementsEnsure operator compliance with standard operational procedures and company protocolsTrain assemblers on production documentation updatesPromote lean methodologies of one piece flow and 5S in order to sustain production efficienciesWork closely with R&D managers and quality manager to ensure production issues and new products are taken care of promptly and mitigate any effects on the production plansAchievements:Leading on engineering transfer core team for the new product transfer and ramp upDeveloped plan to double production capacity utilizing the same amount of spaceDevelop and monitor annual maintenance plans for company equipment to maximize operating efficiency

Responsible for Irvine site, which incorporates planning, engineering, medical device assembly, 32 , tool room and die maker , injection molding machines, sterilization, customer service, FDA compliance, product development, staffing and training, budgeting and tracking orders from initiation through shipment for several products specifically the Tracheotomy, Stopcock and Imaging Syringe Products. Responsible for tracking critical operating metrics to ensure most cost-efficient delivery of products.Managed 550 employees with high volume production (10 MM molded plastic components and 500,000 finished medical devices per month). Ensure all company and regulatory policies are being administered in conformance with established guidelines.Developed and managed operating budget for facility.Through dedicated team effort re: the Six Sigma Project a net savings of $3 million was perfected for FY01 and inventory turns of 12.Responsible for driving process improvement through the use of Six Sigma/Lean tools and methodology.Assembly relocated to Mexico within a six month projected schedule while simultaneously maintained local operation. Completed project constituted a $2 million favorable variance culminated by focused factory concept in addition to excellent strategy.Process Engineer / Team Leader, Product Development GroupR & D Engineer / Manufacturing Engineer