Amed Resume[1]

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Amed Resume[1]

  1. 1. Amed J AyubiWork Address: Home Address:11800 SW 147 Ave 11755 SW 138 AveMiami, FL 33196 Miami, FL 33186(305) 380-3565 (786) 290-2820 (cell)a.j.ayubi@beckman.com amed1123@yahoo.comhttp://www.linkedin.com/in/amedayubiSummary of Qualifications:16 years of research, product & process development, and manufacturing of Medical Devices and Flow CytometryInstrument for research & IVD applications. Key expertise in flow cytometry, material science (plastics, metals,and ceramics) for machining, injection molding, extrusion, grinding, and bonding offer a unique position todevelop new products and robust manufacturing processes. Total project management coupled with problemsolving skills allows optimized product & process development using FEA analysis, CFD analysis, and design ofexperiments. The ability to document in a QSR/ISO environment and ramping up to meet productionrequirements completes the package.Education & Certifications: • Master in Engineering Management, Polytechnic University (46% completion, currently taking classes) • Bachelors in Science in Engineering, Rockville University • Bachelor in Science - Computer Science, Polytechnic University • Graduate School of the University of Massachusetts Lowell in the College of Engineering, Plastics Engineering program for the Certificate of Graduate Achievement degree • Six Sigma Yellow Belt, Boston Scientific Miami • Six Sigma Green Belt, Boston Scientific Miami • Certificate of recognition as subject matter expert in Molding Processes, Six Sigma, and Plastics Engineering, Arrow International, Inc Training and Development • FMEA, Risk Analysis for Medical Devices, Quality University (Certification # 10828100789) • FMEA, Potential Failure Mode Effect Analysis, Quality University (Certification # 10822100789) • Flow Cytometry & Confocal Microscopy, Purdue University • PIM Powder Injection Molding for metals and ceramics, PENNSTATE University • Sintering Theory, PENNSTATE University • Insertion of Central Venous Catheters, Duke University School of Medicine • Peripheral Access Course # AP-101: Anatomy/Physiology & Catheter related Complications, Arrow Int’l • Peripheral Access Course # PA101: PICC Insertion Techniques & Ultrasound Guided Insertion, Arrow Int’l 1 of 7
  2. 2. Employment History:Beckman Coulter 2010-PresentTechnical Operations New Product Support: Staff Technical Operations EngineerResponsibilities include but are not limited to:As Staff Technical Operations Engineer’s my primary role is to support the Product and Process Development.Integration of new hardware and software designs with new and/or existing chemistry to meetestablished performance expectations, and/or conducting investigations to determine how existinghardware/software designs should be modified to meet new performance requirements, or to be restored topreviously acceptable performance levels.• Use knowledge and skills to create design requirements, development plans, risk assessments, and organize resources to achieve best in class products.• Apply Process engineering principles to instrument system design and characterization to ensure optimal performance.• Use statistical understanding to develop sound test plans with robust acceptance criteria for characterizing, verifying and validating component, subsystem and system level designs.• Collect appropriate data to define, identify, analyze and correct system failures.• Perform both empirical and theoretical analysis; interpret experimental data to formulate conclusions.• Collaborate with the Marketing and Commercial organizations in the translation of user needs into relevant design inputs.• Interact with Quality and Regulatory organizations to ensure new designs and design changes meet or exceed customer expectations for quality, and are compliant with federal and international requirements.• Formulate models to predict, analyze and interpret system behaviors as environmental conditions, or other system components interact to influence results, using modeling tools and simulations.• Responsible ensuring new products are designed for manufacturability.• Track and communicate project status, develop project schedules.• Participate on cross-functional teams.• Responsible for design transfer activities.• Flow Cytometry Standardization for Instrument Quality Control Test. Standardization of instrument manufacturing acceptance test and service installation acceptance test through a Flow Cytometry Quality Control System for all Cytometry product lines to increase overall test reliability, reduce overall test time, improved instrument manufacturing throughput time and reduce cost. The new Quality Control System standardizes the qualification of Cytometry instruments across Manufacturing, Service and the customer. It also correlates to biological measurements. This translates into a repeatable process that insures the quality of the measurements at the end user. The proposal recommends standardization of non-biological & biological reagents, controls & practices for optical mechanical alignment, acceptance test, data collection & analysis. These reduced overall test time by 52.64% of current time for an annual savings of 2,433 hours, and an estimated standard cost savings of approximately 68.68% of current testing cost, providing better practices and controls with higher test reliability. Patent is pending.• Nominated to the 2011 Excellence in Innovation Award. 2 of 7
  3. 3. Beckman Coulter 2007-2009Technical Operations New Product Support: Senior Technical Operations EngineerAs Senior Technical Operations Engineer’s my primary role is New Product and Process Development. The focusis in the development of best overall methods for new product and process release. Additionally, I representSupply Chain Management in day-to-day interactions with various business centers throughout Beckman Coulter.These interactions include the activities of resolving concurrent engineering issues and development of newprocesses, methods, techniques, tooling for fabricated parts, components, subassemblies, and products, bothnew and existing. As a senior level team member, I model and support other team personnel in execution ofoverall department strategies.As a part of the hands-on aspect of the role, I interface with Business leaders, Development teams, Qualityrepresentatives, Production personnel, Purchasing individuals and Suppliers providing technical support andleadership in new product development projects. I coordinate the release- to- manufacturing both new andenhancements of existing products; leading and participating in design reviews, conducting DFMA analysis,PFMEA, developing product structures, and process architectures.I also participate in the selection of new suppliers and resolution of technical issues ensuring that manufacturingprocess documents are created and training implemented in compliance with company standards, ISO and cGMP.• Engineering lead for all aspects of process development including the design, prototyping, testing (verification and validation) risk management/process FMEA, process characterization, and documentation. Lead the redesign of existing processes to improve quality, utilize automated production techniques, optimize process capabilities, and produce better products in a more cost-effective manner.• Independently plan and technically lead multiple projects utilizing project plans and schedules to track and communicate developments from prototype design through pilot and into production. Formulate decisions to facilitate project advancement independent of supervisor.• Identify and create new process concepts. Design and validate processes and components using engineering principles and adhering to the design control process.• Advise other engineering personnel on technical aspects of product/process design and the validation of processes including installation qualification, operational qualification, and performance qualification.• Lead, conduct and participate in design and technical reviews.• Independently interface with product development engineers, manufacturing and lab technicians to design and develop new fixtures, tooling, and machinery. Lead the qualification of required manufacturing processes. Train and assist new engineering personnel on product design development, documentation, and manufacturing related processes.• Development and implementation of repeatable and reliable alignment & optimization controls, biological and non-biological scatter alignment verification test, resulting in a 25% pre-final & final test cost reduction ($195K/year) for Gallios & Navios Flow Cytometer product lines.• Successfully completed design transfer activities for new Gallios & Navios Flow Cytometers.• Currently I am supporting the development of a new Clinical Research System Cytometer and a new sorter.• Received the 2009 Excellence in Innovation Award. 3 of 7
  4. 4. Arrow International 2005-2007Global Critical Care Product/Process Development: Sr. Product/Process Development EngineerUnder minimal direction, I was responsible for the design, development and maintenance of PICC (PressureInjectable Central Catheters) for peripheral insertion; organized and managed multiple projects insuring projectswere completed on time. Lead and coordinate all technical phases of product and process development tosupport new product developments, sustaining engineering efforts, cost reductions and design/manufacturingtransfers under design control and product to market process. • Engineering lead for all aspects of product and its respective process development including the design, prototyping, testing (verification and validation) risk management/process FMEA, process characterization, and documentation. Lead the redesign of existing products and/or processes to improve quality, utilize automated production techniques, optimize product and/or process capabilities, and produce better products in a more cost-effective manner. • Independently plan and technically lead multiple projects utilizing project plans and schedules to track and communicate developments from prototype design through pilot and into production. Formulate decisions to facilitate project advancement independent of supervisor. • Independently interface with clinicians, marketing, product development and manufacturing to understand product requirements and establish design criteria for new products and manufacturing processes. • Lead project team members to meet project objectives, milestones, and target dates. • Identify and create new product and process concepts. Design and validate product, processes and components using engineering principles and adhering to the design control process. • Advise other engineering personnel on technical aspects of product/process design and the validation of processes including installation qualification, operational qualification, performance qualification, and product performance qualification. • Lead, conduct and participate in design and technical reviews. • Interface with vendors to obtain quotations, purchase components, and debug problems with raw materials, production parts and processes. • Independently interface with product development engineers, manufacturing and lab technicians to design and develop new fixtures, tooling, and machinery. Lead the development and qualification of required manufacturing processes. Train and assist new engineering personnel on clinician interaction, product design development, verification/validation testing, documentation, and manufacturing related processes. • Investigation of product complains to determine cause and implement corrective action. • Represent the product development engineering department at hospitals, scientific sessions, and seminars to meet with medical personnel. • Manage indirect and direct reports through performance management. • Lead process development and manufacturing personnel with the transfer of development projects and design changes into production. • Support 510K submission for the new Arrow Pressure Injectable PICC’s, Models: 5 French 2 lumen 60cm Trimmable, 5 French 2 lumen 40 cm Blue Flex Tip (non-trimmable), 4 French 1 lumen 60 cm Trimmable (K061289 approved Aug 24, 2006). • Responsible for the design transfer of Arrow’s Arrow Pressure Injectable PICC’s, Models 4FR & 5FR catheters (completed delivering stable and capable processes). • Implement scientific methods for process development (injection molding & extrusion). 4 of 7
  5. 5. • Designed and develop new 6FR 3-lumen pressure injection PICC. • Responsible for D&D plan for new 6FR 3-Lumen pressure injection PICC. • Team member for the introduction of anti-microbial agents for Cannon and PICC catheter product families. • Team member for the design and development of new 7FR pressure injection CVC. • Champion for design tools as Finite Element Analysis & Computational Fluid Dynamics.Boston Scientific – Miami Technology Center1999-2005Plastics Department: Sr. Engineering Technician /J r. EngineerUnder minimal direction I was responsible for the design and development and maintenance of 2.2mm Gastro-Intestinal Biopsy Forceps with radius jaws. Provide technical expertise support for the manufacturing operation inthe areas of process control, troubleshooting, maintenance of equipment, process and yield improvements,training, new products, new tools, part design, process development, plan and performed IQ/OQ/PQ/Product-Process PQ, Product Performance PQ, and reports. • Key expertise on Mold design for new products • Key expertise on Mold design improvements for existing products • Expertise in Parameter and Tolerance Design, Product/Process capabilities studies and strategies • Developed plastic injection molding processes to reduce cost and improve quality • Supporting internal product development and production • Managed molding development projects under tight timelines to assure consistent supply of parts • Coordinated production with materiel to improve efficiency and satisfy production requirements • Documented and validated processes for FDA/QSR/GMP compliance • Validated and qualified equipment/tool for use in internal production • Statistical analysis of data results for qualification and process control (Cpk, Ppk, Histograms, etc) • Develop sampling plans for qualification of new processes • Implemented DOE techniques for development of new molding processes • Acquired new equipment to streamline production and improved quality • Transfer of Powder Injection Molding processes and equipment from Northwest technology center to Miami Technology center • Investigating dimensional control issues in PIM and developed a plan to reduce dimensional variation from 0.3% to 0.1% • Certify MoldFlow Molding software simulation operator • Certify Pro/E software operator • Developed a CIM (Ceramic Injection Molding), de-binding and sintering process for the Universal Gold Probe Tip (75.5% in cost savings and improve quality). • Development work for the MIM (Metal Injection Molding) of Biopsy forceps components (Jaws). This project generated over $1.5 million in cost savings (cancel process was transfer to new Costa Rica facility). 5 of 7
  6. 6. Watson Laboratories – Miami 1999Quality Assurance Department:Was responsible to provide requirements for the establishment and maintenance of a calibration system tocontrol the accuracy of measuring and test equipment and measurement standards used to assure that thesupplies and services comply with prescribed technical requirements. • Create database of test and measurement equipment. • Create a calibration file system and record keeping. • Develop and implement calibration procedures for all measurement instruments, calibration standards and test equipment. • Validate, qualify and implement new pharmaceutical equipment, measuring instruments/equipment, calibration standards, and its processes and procedures.Cordis a Johnson & Johnson company 1995-1999Diagnostics Department: Sr. TechnicianProvide technical expertise support for the manufacturing operation in the areas of process control,troubleshooting, maintenance of equipment, process and yield improvements, training, plan and performedIQ/OQ/PQ’s, and reports under a Team work environment. • Team leader of the Bump N’ Grind SMIT (Self Manage Improvement Team) Team • Increased grinding catheters productivity by 300% • Decreased machines downtime from 40% to 5% (In-feed & Through-feed Grinders, Cincinnati Molding Machines) • Developed equipment maintenance program and procedures • Reduced reject rates from 8% to 1% • Decrease grinding process time from 16 days to 3 days • Implemented & qualified continuous flow process for the grinding operations • The above mentioned projects generate over $865,600 • Developed leadership across all team members • Automate manual grinding operations • Qualified and Implemented 18 Catalog numbers of Nylon Tips (Infinity 4FR/5FR/7FR Super-Torque 7FR/8FR Through-Lumen 6FR/7FR) for diagnosis catheters on an in-feed grinding operations, thus generating over $200,000 in cost savings  The team achieved a 1999 RIT/USA TODAY National Quality Cup Semi-Finalist status, Manufacturing categorySelf Employed 1994-2002PC/Network Specialist:Assembly, set-up and configuration of personal computers, network stations, servers and LAN networkenvironments. • Provide remote technical support, troubleshooting, upgrading, and repairing • Y2K test and provide solutions to compliance • Provide training to new PC users such as introduction to WIN 95/98/2000/ME, Microsoft office 95/97/2000 6 of 7
  7. 7. Development and Training: • Certificate of General Education Development, Hialeah Miami Lakes High School • Biotechnology, Combustion Science, Fluid Physics, & Material Science, NASA Ground Research • Team leader & Facilitator training, Cordis Corp. • Statistical Analysis, Cordis Corp. • Presentation Skills, Cordis Corp. • Microgravity Science Laboratory, NASA MSL-1 (µg) (1g program) • Sintering Theory, NASA MSL-1 (µg) (1g program) • Medical Device Quality Systems Manual, FDA Cordis • Problem Solving, AQP national team conference • Six Sigma, AQP national team conference • Microsoft Pre-installation Specialist, Microsoft OEM system builder program • Personal studies of computer hardware and software (Assembly, setup and conf.) • ARBURG ALLROUNDER “S” & “C” molding press machines, ARBURG • PLC Fundamentals & Troubleshooting I & II, Llewellyn Technology • Systematic Decoupled Molding, RGJ Inc. • DOE Experimental Design for Injection Molding • Pro/ENGINEER, PTC Alpharetta, GA • MoldFlow Plastics Insight, Wayland, MA • Thermogravimetric/Differential Analyzer (TG/DTA 6300), Thermo Haake • PolyLab System (Batch Mixing, Extrusion, Compounding), Thermo Haake • Rheoflixer Capillary Rheometer, Thermo Haake • MoldFlow 3.1 Plastics Inside, BSC Miami • Intralink 3.0 PTC, BSC Miami • MoldFlow 4.0, Online • Advance Hot Runner Molding Systems, Mold Masters Academy • Project Management, Cadence @ Arrow International • COSMOS Design Star FEA & CFD, COSMOS @ Arrow International (provide by COSMOS/SolidWorks)Interests & Activities:Member of S.P.E Society for Plastics Engineering, Member of ASQ American Society for Quality, Injection MoldingMagazine, CDER Center for Drug Evaluation and Research (FDA) member, CDRH Center for Devices andRadiological Health (FDA) member, Space-Lab Research NASA member, CISP Center for Innovative SinteredProducts (PENNSTATE University) member, MPIF The Metal Powder Industries Federation member, MedicalDevice & Diagnostic Industry member.Computer Skills:Microsoft Windows ™ Operating System: Win 3.xx, Win 95/98/ME/2000/XP/Vista/7, MS DOS, NewTechnology™ (NT), and Novel.Application Software: Microsoft Office™ 95/97/2000/XP/2003/2007, (Excel™, PowerPoint™, Money™,Outlook™, PhotoDraw™, Picture It™, Publisher™, Front Page™, Auto Cad, Solid Works, Pro/E, MoldFlow,StatGraphics, DOE Wisdom, SAP, Intralink, Design Expert, Essential Experimental Design, Essential Regression,Microsoft Project™, Minitab, Visual Basic, C++, COSMOS Design Star FEA & CFD.Assembly and configuration: All computer hardware, software and peripherals, Molding Machines, AutoGrinders (through-feed & in-feed), Molds, Molding hot runner systems, die fusing, Flow Cytometers & Sorters,and others (fixtures).Technical support: Provide remote technical support, troubleshooting for computer hardware and softwareproblems on molding machines, temperature control systems, dryers, PC, vacuum systems, and others. 7 of 7

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