Project Manager & Sr R&D Engineer Medical Devices & Converting Equipment
I am Genival Barros, specialist in the introduction of new products,
processes, equipment, and project management. In my capacity, I work
providing coordinating technical support for manufacturing process. Work
with R&D in the research, design, and development of new processes and
products, applying principles and techniques of project management,
mechanical engineering, and mathematical analysis.
Coach and coordinate the work of technicians and junior process engineers.
Help, and many times, take the lead of troubleshooting problems in the
product lines.
Work closely with regulatory affairs, in order to make sure that all
processes, procedures, and validations do comply with the rules set by the
regulatory agencies. Provide project management, troubleshooting, and know
how support to overseas plants.
Summary
> Team leader who thrives working with cross-functional teams, designing
and developing effective, efficient, scalable, and high quality
processes and equipment through the application of engineering and
Lean/Six Sigma principles.
> Customer focused hands-on project manager, driving projects towards
results. Creative thinker with sharp analytical skills. Problem solver
and Creator of solutions that are simple, cost effective, and focused on
the future of the manufacturing process (Certified 6-sigma Black Belt).
> Lead design, development, fabrication, commissioning, and full
implementation into manufacturing of new technology, tooling, fixtures,
equipment and automated systems for pilot and/or manufacturing processes.
Support the continuous improvement of legacy production lines.
> Outstanding training and coaching skills, helping engineers and
technicians achieving their fullest potential in a short time.
> Expertize in: manufacturing, cost reduction, statistical comparison &
analysis, manufacturing performance indicators, OEE increase,
productivity generation, process development, operations, strategy,
logistics, lean manufacturing, capital projects & business case.
> Over 15 year experience as an engineer in: Plastic & Paper film handling
& Converting, Coating, Drying and converting of Films & papers,
Equipment design, robotic factory automation, aseptic environment, device
manufacturing, micro-fluidics, OEE, SPC, Process Improvement, KAIZEN, Six
Sigma.
Career Achievements
> Led project teams in a series of Lean manufacturing projects. Implemented
SPC in key parts of the manufacturing process. Increased output of
manufacturing in 30% at the same time that increased capacity of process
bottlenecks in 50%.
> Introduced slot coating technology producing precise deposition of
chemistry layers on diabetes sensors. Conducted series DOE's that led to
the elimination of defects such us sensor run ups, delamination, and
signal variability.
> Successfully created and deployed high volume equipment that measures
Electrochemical Impedance Spectroscopy (EIS), which helps predicting the
performance of a sensor and eliminated destructive tests, saving more
than $3M in investments.
> Created a novel method of metal electroplating, which improves the
quality of the metallization, at the same time that reduces the process
cycle time in 5x.
> Through a series of engineering studies, found the root cause of an
occurrence that caused the signal of a considerable number of sensors to
fall out of the specification. The elimination of the problem, prevented
the loss of more than 10% of the sensors produced during many months,
which saved $Millions in revenues.
> Decreased the change over time of a slot coating line from 3 hours to 50
minutes, through the application of lean manufacturing and Kaizen
techniques.
> Solve a problem of dimensional stability on laminated flexible circuits
of copper and polyimide, though DOE and least-squares calculations that
resulted in savings of more than US$ 250 K / year.
> Created a process of stabilizing surface tension of substrates to solve
the problem of bond variability on flexible films through the application
of Six Sigma and Shainin techniques, which resulted in savings of nearly
US$ 400 K / year.
> Eliminated the incidence of de-wet problems by controlling viscosity of
the adhesive and surface tension of the substrate, which resulted in
savings of nearly US$ 50 K / year.
> Lead a Kaizen event and implemented the actions derived from it,
preparing a new site for high volume production of digital media paper
that resulted in: 1) Reduction of the shop floor area to 40% of the
original; 2) reduction of the headcount to 70% of the original; 3) The
event will generate savings of more than US$ 2 millions / year.
> Improvement of the production process of a facility for the production of
digital media paper. Removal of bottlenecks and constraints; reduction of
the waiting time in the line; automation of all labeling process; and
troubleshooting of the slitting equipment. Results: 1) increase of 15% in
the throughput; 2) Reduction of 40% of the overtime.
> Decrease the contamination of the product to six sigma levels by
designing a new filtering system for adhesive and cleaning fluids that
contacted the substrate. In addition to that, the pressure drop of the
delivery system was reduced, which eliminated the pump cavitation when
operating with adhesives of high viscosity. This project resulted in
savings of nearly US$ 70 K / year.
> Redesigned the whole process of filtration, flow control, and coating of
water base adhesive at the manufacturing of flexible circuits, which
resulted in the increase of capacity of nearly 300%.
> Development of a new palletizing system, eight times cheaper than out of
the shelf models in the market.
> Managed a project of installation of a new workcenter to produce digital
media paper. The project took 6 months from inception to end. Results: 1)
More than US$ 1 million / year savings; 2) The new workcenter is the
leanest workcenter of the entire paper flow. It has been used as a case
study for lean manufacturing.
> Implemented a project to increase flexibility in the workcenter with the
second highest volume of color paper production. Results: 1) Doubled the
number of product to run at the workcenter; 2) Increase the workcenter
efficiency in 3%, even with the increase in the number of change over; 3)
increase equipment utilization in 30%.
> Implemented a project to increase the flexibility in the workcenter with
the highest volume of color paper production. Results. 1) Triple the
portfolio of products at that workcenter; 2) creation of many innovations
to decrease change over time. Example: magnetic rod retainers, multi-
diagram adjustment of the conveyance system, static dissipative
adjustable spacers for the slitter knives, added devices to cope with the
different weight and inertia of the new products.
> Led the research and replacement of all knives used in the slitter
equipment from steel to an extra-hard composite. Results: 1) Saving of
more than US$ 500 K / year; 2) Extended the life of the knives from 7
days to 3 ~ 4 months. In some cases it can reach 12 months.
> Managed a Six-Sigma project to increase the rates of the packaging line
of the workcenter with the highest production volume of paper. New
automated machines were integrated to the line, and manual labor was
replaced. Result: 1) increase in the rates of the workcenter in 20%; 2)
headcount reduction of 30%; 3) Generated savings of more than US$ 1.5
million / year.
> Managed several projects of reduction of constraints in the packaging
line and cycle time reduction in the manufacturing equipment. Result: 1)
increase in the overall efficiency from 55% to 80%; 2) Decreased
equipment cycle time in 20%; 3) Overall rates of the workcenter were
increased in more than 70%.
> Managed projects to decrease the process change over time of the major
paper workcenters, through SMED techniques. As a result the average
change over time dropped from 125 to 9 minutes
Experience
Sr. Principal Process Engineer, Medtronic Co, CA from 2009 to Date
> Glucose Operations Principal Engineer for fabrication and assembly of
blood glucose monitoring sensors.
> Responsible for all phases of the manufacturing including production and
process development, capacity increase, cost reduction, FMEA,
characterization, Gage R&R, IQ/OQ/PQ, factory acceptance, and supplier
quality.
> Successfully managed deployment and qualification of equipment;
developed, characterized and qualified new manufacturing processes,
established performance metrics and quality specifications; and balanced
process capacity to support a high volume > $130M revenue business.
> Responsible for producing technical documentation for the implementation
of new manufacturing processes, including: Master Process Plan, FMEA,
Process Mapping, process documentation (operating procedures and training
materials), material and quality specifications, equipment
specifications, fixture drawings, and layouts.
> Keep up to date with the latest advances in technology, industry trends,
and establish networks to help identifying emerging technologies with the
potential to enhance quality and manufacturing capability of actual and
future Medtronic products.
> Develop technical specifications (user requirement specifications), lead
sourcing activities, and act as the liaison between vendors and internal
customers to ensure custom equipment and new technology meets process
needs.
> Construct business cases, project plans, charters, and capital
appropriation requests for the evaluation and implementation of new
equipment & technologies. Hold periodic meetings with projects
stakeholders. Coordinate schedule and tasks with project team and
external resources, in order to meet the business needs.
> Create process key performance and quality indicators, such as: cycle
time, takt time, line capacity, line yield, rejects rate, OEE, labor
cost, material cost, process performance (Ppk), process capability (Cpk).
> Develop and execute design of experiments (DOE) and characterization
studies based on solid statistical techniques for quality / process
improvement, technology evaluation, feasibility, and proof of new
concepts. Effectively communicate conclusions through presentations,
technical reports, test reports, and lab notebooks.
> Support technology transfer between sites. Engage in troubleshooting
activities of on-going manufacturing processes. Lead cross-functional
teams and contractors in tasks and projects. Integrate the execution of
activities with change control management. Assist with regulatory
submissions.
Sr. Process Engineer, Bekaert Special Films, CA from 2007 to 2009
> Actively supported the Coating & Lamination process with statistical
techniques (OEE, DOE, 6 Sigma, Paired Comparison, etc) with great impact
in reducing defects, variability, waste.
> Great experience with processes of mass and heat transfer, hydraulic,
pumps, drying ovens and optical film processes.
> Devised novel methods of measurement and test of optical films, adhesion
properties, and physical and thermal properties of polymers (DMA,
calorimetry, etc)
> Designed and execuioned DOEs to develop and enhance manufacturing
processes. Working on the application of engineering quality tools such
as SPC, root cause analysis, FMEA.
> Proviced statistical analysis and engineering planning for the
qualification of new products.
> Make use of analytical tools for troubleshoot the manufacturing process,
in order to find and eliminate the root cause of problems such as lines
of near impossible detection, splice scratches, optical distortion, dry
spots, contamination, and others. Played active role on the analysis and
solution of corrective actions.
> Maintained and optimized running parameters such as fluid steady flow
with real time feed back, line speed, we tension, oven temperature
gradient zone by zone, and others that greatly improved the optical and
physical properties of Bekaert special films.
Sr. Process Engineer Rogers Corporation - AZ, from 2005 to 2007.
> Provided engineering expertise to reduce process variability, reduce
defects, reduce change over time, and increase the OEE of two coating and
laminating work-centers. At Rogers the coating operation utilizes 7
different types of adhesive, applied at 9 different thicknesses, on 10
different substrates of 6 different gauges. The lamination operation
utilizes 10 types of films, and 7 types of copper.
> Optimized running parameters of line speed, tension, oven temperature,
lamination temperature & pressure.
> Provided support to the laminating process, achieving great success on
reduction of defects, variability and waste.
> Applied Shainin and Six Sigma techniques to troubleshoot the process
problems, find the root cause and implement permanent solution.
> Planed and performed series of DOE's and created mathematical-dynamic
models of the laminating / coating process, in order to provide process
optimization and solution for the major problems.
> Improved the performance of hydraulic system of fluid dispensing and
filtering system, by decreasing pressure drop, improving efficiency of
the filtering system, and providing parts of easy change over.
> Reduced variability of the finishing process (slitting & editing).
Decreased the lead time of the sequence of operations. Eliminated all
possibilities of surface defects being generated at the finishing area.
> Worked actively with R&D on the qualification of new products.
Qualification of new process parameters by performing statistical
analysis of the products under the new process against production as
reported. Ensured that new processes and products met and surpassed
specifications.
> Coordinated multi-functional teams (industrial staff, R&D, Marketing) to
develop new products.
> Starts-up new products and equipment. Managed installation,
troubleshooting initial production.
> Supervised engineering assistants and industrial staff. .
Sr. Process Engineer Eastman Kodak, Rochester - NY from 1999 to 2005
> Provide technical support to manufacturing. Help troubleshooting the
equipment. Manage and install projects.
> Provide technical support for three high volume and two custom
workcenters. Each workcenter is composed by a state of art
slitter/spooler equipment and an automated packing line.
> Create and Lead projects of process design, process improvement, and
installation of new equipment to improve the process.
> Prepare project feasibility study, form cross-functional team, create
work breakdown structure, and prepare schedule & budget. During
execution: make sure that the project follows the schedule and budget,
and work at the execution with the team to assure that the project meets
its objectives.
> Create business cases to evaluate and prioritize projects of capital to
maximize asset utilization.
> Create, participate and Lead Kaizen projects and strategies to improve
productivity, maximize performance, increase reliability, and reduce
waste in the process and in the equipment.
> Research, analyze, and start up projects of capital to improve
productivity, performance, and quality.
> Form and lead cross-functional teams to conduct projects, or to attain
short and medium term targets.
> Create, modify, and implement equipment change specifications.
> Lead cross-functional teams into process improvement, Kaizen initiatives,
and analytical troubleshooting.
> Support troubleshooting in all activities at the manufacturing
environment.
> Create performance / cost measurement tools. Track process downtime and,
through six sigma tools, prioritize improvement activity.
> Help and coordinate overseas capital projects, to allow all worldwide
sites to benefit from improvements created elsewhere.
Project Engineer Kodak of Brazil, Manaus - Brazil from 1997 to 1999
Manage projects, provide technical support to manufacturing of color paper
and health image products
Achievements
> Increased process overall effectiveness of the color paper production
from 50% to 82%, from 1997 to 1999.
> Increased production capacity of the paper finishing workcenter in 30%.
> The above projects reduced the number of working hours in 44%, while
keeping the production volume.
> Improve the quality standards of X-ray and paper sheet process to 6
SIGMA levels
> Technical Support to paper rolls, sheets, and X-ray finishing process
Automation Engineer Gradiente Electronics, Manaus - Brazil from 1996 to
1997
Provide technical support to the installation of new SMD machines for
printed circuit board assembly. Work as an automation Engineer for the
production of wide screen color TV and stereo systems.
> Developed business case comparing different scenarios for the
construction of a new manufacturing facility. The study involved cost x
benefit, capacity analysis, change over frequency and efficiency of
machines for automated assembly available in the market. Example machines
considered are: Universal through hole insertion machines, Siemens
parallel SMT assembly machines; and Fuji modular, as well as high speed
SMD assembly machines.
> Installation and start up of two new Fuji CP-6 SMT machines for the
assembly of printed circuit boards.
> Increasing manufacturing throughput of TV sets in 50% through
application of the theory of constraints.
> Increase the throughput of Stereo system production lines in more than
45%
> Development of skilled labor force to support the company in automation
technology
> Provide technical support to consumer electronics manufacturing
Software Experience
> MS Office Package, Outlook, Visio, Minitab, Matlab, Lotus Notes,
Infinity, Visual Basic.
> Design of dies, machine parts, and machines, as well as computer
simulations. Advanced user of SolidWorks, Alibre, and on AutoCAD.
Education and Certification
MS Manufacturing Management Rochester Institute of Technology,
Rochester - NY
. Alumni award
MS Mechanical Engineering Kagoshima University, Kagoshima - Japan
. Kagoshima city award
BS Mechanical Engineering Amazon State University, Manaus - Brazil
> Advanced Project Management - Medtronic - Los Angeles, CA,
> Advanced Risk & Cost management - Medtronic - Los Angeles, CA,
> Minitab Statistics - Rogers Corporation - AZ
> SHAININ Manufacturing Troubleshooting Techniques - Detroit, MI
> Six Sigma Black Belt - Kodak, Rochester, NY
> Coating and Adhesion Technology - Waltham, MA
> Language Skills: English, Portuguese, Spanish, and Japanese
> Project Management - Rochester, NY
> Advanced SolidWorks Design - Rochester - NY
> Advanced Alibre 3D Design Software - Rogers Corporation - AZ
> Kaizen Implementation - Kodak, Rochester, NY
> Programmable Logic Controllers - FESTO
> Industrial Robots - ABB
> Operating Systems: Windows XP / Windows 2000 / UNIX / Linux / Mac
> Applications: Lotus Notes, MS/Office Professional / MS/Project / S/VISIO