Engineer Design
Resume:
Miramar, FL *****
Micrus Endovascular
Miramar, FL 33025
Dear employer,
By means of the proper, I would like to formally apply for the available
Associate R&D Engineer position. I have read the corresponding job posting
and I am certain that my ingenuity, knowledge and industry experience make
me an excellent candidate for it.
Congruous with the requirements of the position, I have worked in the
medical device / pharmaceutical industry for more than three years;
reporting directly to the Technical Operations and Development groups of a
federally regulated company. Consequently, as a byproduct of substantial
experience with good documentation practices, process controls, and root
cause investigations, I am rather familiar with Quality System Regulations
(QSR) and Good Manufacturing Practice (GMP) guidelines. I have participated
in various product / process transfers (at an international scale) and I
have been formally lauded for the outstanding executions of the pertaining
validation activities (i.e., IQ, OQ, PQ & PPQs). Similarly, as a black belt
certified engineer, I have completed several characterization and
optimization projects, in instances improving process capability from 0.23
Cpk to 2.14 Cpk.
I am quite interested in employing my experience and knowledge on the
endovascular sector, and so, it is with great enthusiasm that I submit this
application. I am ready to make a sizeable impact as a member of your R&D
team, and I look forward to doing just that. Consequently, please find my
contact information on the header section of the adjunct resume.
Sincerely,
Andy Senda
Summary
Innovative, technically strong, Six Sigma black belt certified
engineer with experience in design, development, and improvement of
manufacturing processes, medical devices, and pharmaceuticals. Skilled
in all phases of product development - from design concept to
commercialization - with emphasis on User Requirements, Technical
Design Inputs, Validations, and Statistical Methods. Adept in critical
thinking, with a marked propensity of turning challenges into simple,
efficient solutions. Bilingual, English & Spanish. Proven track record
of successfully managing projects and cross-functional teams in and
outside of the US. Strengths and areas of expertise include:
?User Requirements ?Characterization ?Root Cause
Analysis ?Physics
?Technical Design Inputs ?Supplier Assessment ?Risk
Mitigation ?Communication
?Cross Functional Teams ?Process Validation ?Process
Transfers ?Mathematical Methods
Skills / Abilities
Statistical Tools: Capability, Gauge R&R, COV studies, IMR
charts, Xbar R charts, ANOVA, t-Test, f-test, DoE,
Regression, Reliability Analysis, etc.
Computer Software: MiniTab, SolidWorks, Matlab, Microsoft Office,
Visual Studio, SQL Server, Dreamweaver, Flash
Computers Languages: C#, SQL, PHP, ASP, HTML, mySQL
Experience
Johnson & Johnson, Cordis Corporation Miami Lakes, FL
2006 - Present
Worldwide leader in the development of interventional vascular
technology
Sterilization Engineer (2009 - Present)
Supported process improvement projects related to Ethylene Oxide
sterilization cycles. Developed and reviewed sterilization validation
and yearly requalification documentation. Created and work on problems
and projects where data or situation analysis was required to identify
key factors and appropriate courses of action. Selected design
directions and design changes to meet requirements and specifications.
Supported manufacturing builds and provided guidance to colleagues.
. Designed an automated Pleat / Fold machine for the Ireland
facility, which resulted in foot print reduction,
bidirectional product flow, and real-time product damage /
process error detection
. Designed and characterized the second generation of transfer
fixtures and stent cartridges, which reduced inventory space
and eliminated bottle necking
. Executed further characterization and 3rd design iteration of
the stent cartridge and transfer fixture with focus on
operation control and risk mitigation. Resulting design had
an error proof loading configuration, commingling prevention,
and locking mechanism for product protection
Process Development Engineer (2007-2009)
Worked on problems and projects where data or situation analysis
was required to identify key factors and appropriate courses of
action. Selected design directions and design changes to meet
requirements and specifications. Supported manufacturing builds and
provided guidance to colleagues.
. Designed an automated Pleat / Fold machine for the Ireland
facility, which resulted in foot print reduction,
bidirectional product flow, and real-time product damage /
process error detection
. Designed and characterized the second generation of transfer
fixtures and stent cartridges, which reduced inventory space
and eliminated bottle necking
. Executed further characterization and 3rd design iteration of
the stent cartridge and transfer fixture with focus on
operation control and risk mitigation. Resulting design had
an error proof loading configuration, commingling prevention,
and locking mechanism for product protection
. Completed a process optimization project, using Six Sigma
methodologies, which resolved Investigational Device
Exemption (IDE) failures and reduced product damage
. Assisted in the development of software packages for
manufacturing equipment, which optimized the Graphical User
Interfaces from an ergonomics and cycle time standpoint
. Transferred (to Ireland) and validated manufacturing
equipment and ancillary tools, which resulted in fully
integrated Crimp and Pack development laboratory
Entry Level Development Engineer (2006-2007)
Performed assignments to develop professional work knowledge and
abilities. Participated on routine tasks developed to provide
experience and familiarization with engineering methods, practices,
and standards.
. Executed and completed failure investigation / improvement
project (through the use of the DMAIC method) which enhanced
process capability from 0.23 Cpk to 2.14 Cpk
. Drafted and executed validation protocols (IQ/OQ, PQ, PPQ) in
Puerto Rico, which was required for ISS builds before product
release. Received an Encore Award for outstanding performance
. Developed maintenance procedures and operating procedures
(Puerto Rico) to help keep the lines properly functional and
avoid unnecessary down time and production fall-out
Education
University of Miami, Miami, FL
Bachelor of Science in Biomedical Engineering (Electrical)
Level of Academic Distinction: Cum Laude
Professional License & Affiliations
Tau Beta Pi (Engineering Honor Society)
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