Medical Device Engineer
Resume:
YANDONG SU
**** ********** **** *******, ******* 30339
*********@*****.***
SUMMARY
A reliable, results-oriented and quality-driven engineer with over 10
years experience in the biomedical industry with proficiency in
medical device design, design verification testing, product validation
testing and physician training with an in-depth knowledge of current
GMP, GLP, Quality System Regulations. Secure interacting with
physicians, research scientists, suppliers, contract manufacturers,
consultants, quality personnel, regulatory affairs personnel, and
external consultants.
EXPERIENCE
Aderans Research Institute (Bosley Medical group AFFILIATE) Atlanta,
Georgia
Senior Engineer 2003-2013
< Invented bald head fixture for product training, Co-Inventor of
micrometer assisted delivery system, and ARI-PEN cell injection
device.
< Developed clinical doctor medical device training protocol,
coordinated the clinical training program that successfully completed
training of more than 80 physicians from different clinical centers
worldwide successfully in the use of the ARI MADS and ARI-PEN cell
product injection devices.
< Evaluated clinical doctors' qualification based on injection pathology
test results.
< Summarized inventors design ideas and unmet needs from clinical users
to initiate design plan.
< Designed delivery device prototype using Solidworks.
< Completed training report and certified doctors based on statistical
analysis of injection depth and cell delivery quality.
< Completed design validation testing and failure test of the invented
medical devices.
< Completed IQs, OQs, PQs and PVs and developing report packages to
approve equipments (Bio-analyzer, Cryostat, Microtome, Automatic
Tissue Processor and Microscope, etc.) and processes (Frozen tissue
histology preparation, In-vitro/in-vivo tissue sample dehydration
preparation, etc).
< By executing six sigma theory and problem solving skills, define the
cell culture media shelf life.
< Validated delivery device function utilizing pathology and bio-
compatibility studies as well as other mechanical methods.
< Simplified training procedure by designing the portable bald head
fixture and improved In-vivo training to In-vitro on-clinical-Sites
training. This change saved approximately $500,000 annually in
training program expenses.
< Managed analysis and interpreted bio-analyzer media concentration test
results as well as clinical trial data from Phase-I and Phase-II
studies using statistic analysis and developed report packages to
support qualifications/validations.
< Established stability and acceptable safety range of each component in
cell culture media with data analysis of blank culture media testing.
< Reduced cell feeding frequency, cost, and risk of contamination
through data analysis of spent culture media testing.
< Developed proficiency and working knowledge of GLP, GMP and GTP
regulations as required for production of Biologic and Medical device
products.
< Specifically trained in using Lotus Notes databases for reports,
protocols, experiment designs and all the internal and external
references applications in all the projects and experienced in
collecting data with SAP.
< Experienced in the area of sterilization of equipment, tools and other
non-disposal parts of medical devices using gamma, steam, ETO and HVAC
system.
< Trained in FDA Quality System Regulations.
Beijing Aeronautics Manufacture Technology Research Institute Beijing,
China
Engineer 1998-2001
< Created 3D models, animations, and detailed drawings using SolidWorks
for $30,000,000 civil air-craft skin laser welding technology project,
including testing and validation of turbine blade molds and strength
and stress test of joint.
< Developed laser parameter windows determination including high power
industrial lasers, medical lasers, and ultra prototype lasers.
< Established mathematical modeling of laser welding heat transfer
efficiency to predict weld quality at joint of turbine blade and base.
< Served as team leader in turbine manufacturing project with laser
material processing technology.
EDUCATION
Georgia Institute of Technology, Atlanta, Georgia
M.S., Industrial and System Engineering, 2002
Harbin Institute of Technology, Harbin, China
M.S., Mechanical Engineering, 1996
B.S., Material Science, 1993
CERTIFICATION
Lean Six Sigma Green Belt (Training completed, Project
submitted for Certificate )
Certified as Base SAS Programmer
Biostatistician Training at CFPIE
PATENTS
US Patent, Medical Device 8,206,335, Apparatus and Methods for Delivering
Fluid and Material to a Subject
US Patent, Medical Device 7,780,635, Apparatus and Methods for Delivering
Fluid and Material to a Subject
US Patent, Medical Device, D606,190, Device for Delivering Cellular
Material and Physiologic Fluids to a Subject
US Patent 200********, Medical Device, Hair Grafts Derived from Plucked
Hair
COMPUTER SKILLS
SPSS, SAS, StatGraphics, Minitab, SolidWorks, Auto-CAD
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