• Assisted in the development of a new PIM (Powder Injection Molding) process for the manufacturing of biopsy forceps tips and jaws. This project generated over $1.5 million in cost savings.

1. Amed J Ayubi
Work Address: Home Address:
11800 SW 147 Ave 11755 SW 138 Ave
Miami, FL 33196 Miami, FL 33186
(305) 380-3565 (786) 290-2820 (cell)
a.j.ayubi@beckman.com amed1123@yahoo.com
http://www.linkedin.com/in/amedayubi
Summary of Qualifications:
16 years of research, product & process development, and manufacturing of Medical Devices and Flow Cytometry
Instrument 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 to
develop new products and robust manufacturing processes. Total project management coupled with problem
solving skills allows optimized product & process development using FEA analysis, CFD analysis, and design of
experiments. The ability to document in a QSR/ISO environment and ramping up to meet production
requirements 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
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2. Employment History:
Beckman Coulter 2010-Present
Technical Operations New Product Support: Staff Technical Operations Engineer
Responsibilities 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 meet
established performance expectations, and/or conducting investigations to determine how existing
hardware/software designs should be modified to meet new performance requirements, or to be restored to
previously 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.
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3. Beckman Coulter 2007-2009
Technical Operations New Product Support: Senior Technical Operations Engineer
As Senior Technical Operations Engineer’s my primary role is New Product and Process Development. The focus
is in the development of best overall methods for new product and process release. Additionally, I represent
Supply 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 new
processes, methods, techniques, tooling for fabricated parts, components, subassemblies, and products, both
new and existing. As a senior level team member, I model and support other team personnel in execution of
overall department strategies.
As a part of the hands-on aspect of the role, I interface with Business leaders, Development teams, Quality
representatives, Production personnel, Purchasing individuals and Suppliers providing technical support and
leadership in new product development projects. I coordinate the release- to- manufacturing both new and
enhancements 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 manufacturing
process 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.
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4. Arrow International 2005-2007
Global Critical Care Product/Process Development: Sr. Product/Process Development Engineer
Under minimal direction, I was responsible for the design, development and maintenance of PICC (Pressure
Injectable Central Catheters) for peripheral insertion; organized and managed multiple projects insuring projects
were completed on time. Lead and coordinate all technical phases of product and process development to
support new product developments, sustaining engineering efforts, cost reductions and design/manufacturing
transfers 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).
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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 Center
1999-2005
Plastics Department: Sr. Engineering Technician /J r. Engineer
Under 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 in
the 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).
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6. Watson Laboratories – Miami 1999
Quality Assurance Department:
Was responsible to provide requirements for the establishment and maintenance of a calibration system to
control the accuracy of measuring and test equipment and measurement standards used to assure that the
supplies 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 1995-1999
Diagnostics Department: Sr. Technician
Provide technical expertise support for the manufacturing operation in the areas of process control,
troubleshooting, maintenance of equipment, process and yield improvements, training, plan and performed
IQ/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
category
Self Employed 1994-2002
PC/Network Specialist:
Assembly, set-up and configuration of personal computers, network stations, servers and LAN network
environments.
• 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
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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 Molding
Magazine, CDER Center for Drug Evaluation and Research (FDA) member, CDRH Center for Devices and
Radiological Health (FDA) member, Space-Lab Research NASA member, CISP Center for Innovative Sintered
Products (PENNSTATE University) member, MPIF The Metal Powder Industries Federation member, Medical
Device & Diagnostic Industry member.
Computer Skills:
Microsoft Windows ™ Operating System: Win 3.xx, Win 95/98/ME/2000/XP/Vista/7, MS DOS, New
Technology™ (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, Auto
Grinders (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 software
problems on molding machines, temperature control systems, dryers, PC, vacuum systems, and others.
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