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ENGINEERING STAFF
Merwin
J. "Jerry" Hansen, Chairman &
CEO
Mr. Hansen has been in the medical field since 1977. Over
a period of ten years, he was instrumental as VP marketing
and sales, and later as CEO in the establishment of Humphrey
Instruments as the leading high tech instrument company in
eye care. He moved from Humphrey and became the CEO of the
international division of Santen Pharmaceutical - a major ophthalmic
pharmaceutical company with $800 million in annual revenues.
He served as the Santen International CEO for ten years and
served as a member of the board of directors of the Tokyo Stock
Exchange listed parent company for six years. He has also served
on the board of directors of several privately held companies
specializing in medical devices or ethical pharmaceuticals.
Mr. Hansen has been responsible for the development and successful
world wide commercialization of innovative diagnostic instruments
and surgical devices, as well as the development and worldwide
commercialization of new prescription pharmaceutical products.
He holds a BSME degree from U.C. Berkeley.
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Michael
Forman, President & COO
Mr. Forman has 25 years experience in developing medical devices
in the areas of interventional cardiology, interventional neuroradiology,
oncology and urology. Mr. Forman is an experienced engineering
executive and an active medical device inventor and entrepreneur
with 31 patents.
Mr. Forman’s areas of technical expertise include:
- Laser System Design
- Optical System Design
- Laser Processing of Polymers
- Design of Disposable Devices for Radiation Treatment
- Micromanipulator Design
- Catheter Design (cardiology and neuroradiology)
- Balloon Design
Mr. Forman has extensive experience in conducting Risks & Hazards
analysis for complex products.
Mr. Forman is active in helping companies with Patent Application
Development.
Mr. Forman is co-founder of Xoft microTube, a developer of x-ray
catheters for the treatment of breast cancer. Mr. Forman holds
a B.S. in Physics from U.C. Santa Cruz.
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Ken
McCuen, Chief Technical Officer/Electrical Engineering
Mr. McCuen has more than 25 years experience in managing medical
device product development, as well as semiconductor and instrumentation
products and projects. Ken brings experience in successful
project management, with a track record of on time delivery
and performance to budget. At Circle he has a "hands on" management
style where he works intimately with an eclectic and dedicated
team of electrical engineers and technicians. Ken has an extensive
background in designing for compliance with UL, CSA, CE, and
FCC regulatory agencies. Ken’s areas of technical expertise
include:
- Embedded SW Instrumentation & Control Systems
- Design of EKG Circuits
- Ambulatory Patient Monitoring & Data Recording Systems
- Design of RF Electrosurgical Units
- High Power and High Temperature Control Circuits
- Cryogenic Systems
- Implanted Instruments
- Temperature Measurement & Control
Mr. McCuen holds a B.S.E.E. from San Jose State University. He
has two patents related to instrumentation and control systems.
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Daniel Mufson, Chief
Scientific Officer
Daniel Mufson has 40 years experience in the development and
registration of drug, device, combination and biological products.
Skilled in creating and leading multi-disciplined, technical
teams to create new drug delivery technologies and products—he
built Liposome Technology and Alexza MDC into successful drug
delivery companies. He is President of APOTHERX® LLC
a product development and regulatory consultancy in Napa, CA
and is currently guiding R&D for a start-up ophthalmic drug
delivery company.Most recently he served as Chief Scientific
Officer of Alexza Molecular Delivery Corporation where he led
the development of Staccato™ thermally generated aerosols
and directed the Company to its first IND. He helped to found
Molecular Delivery Corp. which merged with Alexza, founded by
Alex Zaffaroni, in 2002.
For 10 years he headed APOTHERX providing product development
expertise to numerous start-up and global pharma companies including
Cusi (Alcon), DepoMed, ISIS, Japan Tobacco, Ligand, Neurex (Elan),
Novartis, Q.P. Fine Chemicals (Kewpie), Santen and St. Jude Medical.
He was Senior Vice President of Corporate Development and Vice
President for R&D at Liposome Technology, Inc. (ALZA/JNJ)
where he led development to the first INDs for inhalation and
ophthalmic products. Dr. Mufson was Director of Pharmacy R & D
at Revlon Health Care Research (Aventis) and had worked for Smith
Kline & French Laboratories (GSK) and for Parke Davis & Co.
(Pfizer). Dr. Mufson received his Doctorate in Pharmaceutical
Chemistry from the University of Michigan and his B.S. and M.S.
degrees in Pharmacy from Columbia University. He is a Fellow
of the American Association of Pharmaceutical Scientists. He
recently completed a chapter, Integrated Drug Product Development—From
Lead Candidate Selection to Life-Cycle Management for The Process
of New Drug Discovery and Development (Second Edition), editors
Charles G. Smith and J.T. O’Donnell, CRC Press, in-press
(2005).
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Gery Carlson, CFO
Mr. Carlson has over 30 years of experience in public accounting,
internal auditing, and senior finance roles in Silicon Valley. He
brings a hands-on financial management style to several areas
of the company, including financial reporting, financial planning
and budgeting, cash management, human resources management, and
facilities management. From 2000 until September 2006,
Gery was the Corporate Controller and later the Vice President,
Finance and Corporate Controller for Azerity, located in Milpitas,
California. During his years with Azerity his responsibilities
were expanded beyond finance to encompass Human Resources, Facilities,
Legal and IT. Azerity went through a successful acquisition
in 2006. Prior to Azerity, Gery spent 22 years as a CPA
principal in public practice in San Jose, California, working
with a variety of companies in the bay area. Mr. Carlson
has worked as an internal auditor with a major defense contractor
and performed work for the Defense Contract Audit Agency. Gery
has also taught several finance related courses for the California
State Bar Association.
Mr. Carlson holds BSC and JD degrees from the University of
Santa Clara.
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Bob
Ainsworth, Senior VP of Research and Development
Bob has over 30 years experience in R&D, product development
and business development within the Medical Device industry. He
initially worked on product testing and development of orthopedic
devices with companies including Zimmer and Hexcel Medical
(acquired by Stryker Corporation in 1987).
In 1989, Bob joined Advanced Cardiovascular Systems, which became
Guidant Vascular Intervention in 1994, first working to develop
unique cardiovascular catheter shaft structures and later led
technology development teams focused on angioplasty balloon and
stent delivery systems. From 2001 through 2004, as part
of Guidant VI’s New Ventures group, Bob investigated potential
new business technologies including MRI guided interventional
devices, percutaneous heart valve therapies and devices for catheter
based cell therapy.
In 2005, Bob joined Edwards Lifesciences and directed a team
developing catheter based devices and methods for treating mitral
valve regurgitation and intra-atrial septal defects through device
design, bench and animal testing and initial human clinical trials.
Bob is an inventor of 9 US patents and several patent applications
and holds BS and MS degrees in Materials Engineering from Clemson
University and an MBA from St Mary’s College.
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Simon Hawksworth, Vice
President of Sales & Marketing
Simon Hawksworth has 18 years experience in sales and marketing
in the field of design and manufacturing outsourcing - working
for 15 years in the field of medical devices. From 1995
to 2002 he worked at Maxtek Components Corporation and served
in a variety of positions from Business Development Manager through
Sales Director and Vice President of Sales and Marketing. The
primary focus of this business was the design and manufacturing
of complex microelectronics subassemblies for the Medical, Military
and Test & Measurement industry. In 2002 he joined HEI, Inc
as Vice president of Sales and Marketing and was instrumental
in taking this Medical Device Outsourcing Company from $20 to
$56M in revenue in three years. Simon has focussed
on developing effective relationships with Medical Device OEMs.
He is responsible for: Sales & Marketing Strategy, New Business
Development, Account Management and Marketing Communications.
Mr.
Hawksworth holds a BA in Business from Southbank University in
London and an MBA from the University of Westminster in London.
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Robert Short, VP of
Research & Development
Robert has over 25 years experience in R&D and product development
within the medical device, pharmaceutical, and personnel protection
equipment industries. His eclectic background includes
development of liquid cooled garments for medical applications,
development and testing of innovative spacesuit components, development
of diagnostic ultrasound contrast media, and creation of ultrasound
mediated drug delivery systems. His technical expertise
includes microencapsulation, emulsions and dispersions, particle
size measurement, lyophilization of pharmaceuticals, medical
ultrasound, personnel barometric and heat protection systems,
fluid mechanics, and plastics processing. Robert
has experience in project management as a director in several
companies including Life Support Systems, Rasor Associates, Microsome,
and POINT Biomedical Corporation. His background in the
management and implementation of government contracts for NIH,
NASA, and DOD, with their strict requirements for adherence to
budgetary and schedule tracking controls, has instilled in Robert
a strong sense of project discipline which is applied to all
his efforts.
Robert is an inventor on 9 issued US patents with
several others pending and is author on nearly 30 technical reports
and publications. He
holds a BSME from Purdue University, an MSME from the University
of Washington, and has completed project management courses offered
by the AMA.
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Ali Hassan MD, Director
Biodesign
Ali Hassan is a clinical scientist, inventor and an entrepreneur.
Dr. Hassan's research involves vascular disease,
catheter-based techniques, imaging, and the clinical assessment
of medical devices. Dr. Hassan has numerous publications in the
field of cardiovascular medicine, and has acted as an investigator
in large, multi-center clinical trials. Dr. Hassan has also been
active in development of medical devices since 1995: He holds
several cardiovascular device patents; most prominently is the
Differential Density Stent, the TrakBack-TM Pullback Device,
and a system of organ isolation for interventional therapies.
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Rick Stellmacher, Director,
Medical Electronics/Software
Rick has more than 30 years experience
developing hardware and software solutions for diagnostic instrumentation
and medical devices. For
the past 20, years he has held various leadership positions within
development organizations supervising multi-disciplinary teams
of mechanical, electronic and software engineers. Rick
has worked on a broad range of projects from miniature motorized
devices to the complete automation of genomic and proteomic research
processes. Rick ‘s background includes intimate knowledge
of ISO- 9001, FCC, FDA, UL, CSA, FM, CE and other third party approval
agencies. Rick has extensive experience with the design
of hardware and firmware of real-time Embedded Control Systems
and Instrumentation RTOS and device drivers. Most recently
Rick served as the Director of Electrical Engineering at BC Tech. Prior
to that he worked for Lathrop Engineering, Arcturus, LJL Biosystems,
Sierra Monitor, Elecon, Biotech Electronics and ISS Sperry Univac.
Rick is the holder of 5 issued US patents. He holds
a B.S.E.E from California Polytechnic State University,
San Luis Obispo.
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Rajiv Gupta, Instrument
Division Director
Rajiv has over 20 years of extensive experience in managing
innovation portfolios and development of new products from concept
to manufacturing. He has successfully provided solutions and
taken concurrent products from concept to manufacture with product
differentiation, maximizing ROI and gaining competitive advantages
for the clients. Most recent experience includes 9 years in the
design, development and management of medical Instruments for
IVD, Life Science R&D and Drug Discovery fields. He has worked
on a broad range of projects from generic robot development (to
create off the shelf “OTS” plug and play robots),
to the complete automation of clinical and research lab instruments.
Rajiv holds a B.E. Honors in Mechanical Engineering from MSU
Baroda, India and a Post Graduate certificate in Innovation Management
(PCIM) from University of Melbourne, Australia. He has 3 current
patent applications.
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Kimberly Marquez, Director
of Quality Assurance
Kimberly has over 9 years of experience in product development
and operations for medical devices. She has worked extensively
on device development for minimally invasive cardiac surgery
procedures at Boston Scientific, Guidant and Heartport. For
5 years she led product development teams taking concepts through
market release. Her operations experience includes working
as a manufacturing engineer providing process development and
incorporating Design for Manufacturing prior to product launch. Most
recently she was a commodity manager in the supply chain organization
of a major medical device corporation developing supplier quality
improvement plans and optimizing supplier contracts. Kimberly
started her career as a packaging engineer and has developed
packaging and labeling for sterile devices and large capital
equipment. While leading development teams, she has provided
packaging engineering expertise and ensured that thorough validations
and aging studies were conducted for all projects.
Ms. Marquez holds a Bachelor of Science degree in Packaging
Engineering from Michigan State University.
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Chuck
Schwimmer, Director of Industrial Design
Mr. Schwimmer has over 25 years of experience in product development,
most recently including 8 years of experience in the design
and development of medical devices. His medical device experience
includes an extensive range of devices including standard x-ray
and mammography systems, ablation systems, catheter control
devices, infusion pumps, patient diagnostics and monitoring
systems, and biopsy tools. Chuck’s project involvement
includes industrial design, human factors engineering, and
mechanical engineering in addition to project management. He
has substantial experience in medical device labeling including
creating IFUs and labels, and in the development of packaging
for sterile, single-use devices as well as durable devices.
Mr. Schwimmer has previously held roles of Director of Design
and Human Factors, and Director of Product Development.
Mr. Schwimmer has 11 issued patents and one current application.
He holds a B.S. in Design from the Institute of Design at Illinois
Institute of Technology, Chicago IL.
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Anand Ram, Senior
R&D
Engineer
Mr. Ram has over 25 years of experience in the medical
device industry. He is highly innovative engineering professional
with extensive experience in broad range of catheter engineering
including critical care (dialysis catheters), cardiology, urology,
neurology, and specialty catheters such as chorion biopsy catheters,
in-vitro fertilization catheters, CVP catheters, billiary drainage
catheters and catheter based delivery systems. Mr. Ram’s
career began as a production supervisor at Vas-Cath where he
later held various leadership positions within the organization
such as Lab supervisor and R&D supervisor. Mr. Ram lead
nylon balloon development at Vas-Cath where he designed and
produced thin-walled nylon balloon-expandable stent delivery
systems and double-layer, high pressure nylon balloon angioplasty
catheters which are currently sold by C.R. Bard Inc. Mr. Ram
then joined Novoste Corporation as Staff Engineer and led a
team of engineers to redesign their ‘Beta’ radiation
delivery system for vascular brachytherapy. He further designed
a delivery system to treat atrial fibrilation and atrial flutter.
Mr. Ram then joined Shakti Medical technologies as a Program
Manager to develop novel technology for mitral valve repair.
He is skilled in leading and providing support to large and
complex projects.
Mr Ram is a co-inventor of Balloon Angioplasty
Patent # 5015230 and has several patents pending. He holds a
Diploma in Civil Engineering from City and Guilds of London Institute,
Great Britain and a Diploma in Medical and Surgical Instrumentation
from Humber College, Toronto, Canada.
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Adam Matthew Jones, Senior
Mechanical Engineer
Mr. Jones has brought creativity to medical product development
and mechanical design engineering for 3 years. His engineering
experience ranges from proof of concept prototype design and
creation to life testing, problem diagnosis and redesign of production
units. Mr. Jones’s experience includes directing a point-of-care
diagnostic instrument and consumable development team for an
international client.Areas of technical expertise include:
- Injection Molded Part Design
- Design for Manufacturing
- Mechanism Design
- Electro-mechanical Design
Mr. Jones holds a Master of Science in Mechanical Engineering
and Master of Business Administration from California Polytechnic
State University, SLO.
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Jim McCrea, Principal
Engineer
Mr. McCrea is a Principal Engineer with an expertise in product
development and design for manufacturing. Recent projects which
Mr. McCrea has led include an adjustable annuloplasty ring for
the mitral valve, a Jet Injector for mass immunization, and a
catheter based pacing device delivery system. In addition, Mr.
McCrea has experience with injection molded plastics, sheet metal
chassis design, machine design, and motion control of automated
systems.
Mr. McCrea holds a Bachelor of Science degree from California
State University, Long Beach and has three U.S. issued patents.
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James Badia, Senior Mechanical Engineer
Mr. Badia has 10 years experience as a Mechanical Engineer.
Two of those years were with Arterial Vascular Engineering
(currently Medtronic) as an Engineer Intern in the catheter
division. James has been with CMD since September 2005, and
has provided both engineering design and project management
for catheters, suturing devices, implantable cardiac devices,
implantable spinal devices, insulin pumps, and imaging console
projects. For 5 years James was a Process Engineer for an automotive
OEM which supplied automatic transmissions to Toyota. At Cal
Poly, James won the prize of 1st runner up at the California
State University Research and Design Competition, for the design
and manufacture of a working recumbent bicycle. His engineering
experience includes concept/prototype design, design for manufacture,
and high volume production utilizing the Toyota Production
System.
Mr. Badia received his B.S. degree in Mechanical Engineering
from Cal Poly State University in San Luis Obispo.
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Ravin Patel, Sr.
Mechanical Engineer
Ravin has 15 years of product design experience with
the last seven dedicated to medical devices. He has experience
in all facets of device development including research and development,
prototype design and testing, clinical trials and transfer to
manufacturing. He has been involved in the development
of over a dozen successful devices including a catheter based
therapeutic cooling console, a cryoplasty delivery system, an
ambulatory patient monitoring and recording system, an endobronchial
aspiration console and an ocular drug delivery lens.
Ravin
holds a BS in Mechanical Engineering from Santa Clara University.
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Steve Woodard, Principal
R&D Engineer
Steve is widely regarded as an innovative R&D engineer who
provides elegant solutions to difficult problems.
He has led the development of numerous products including endoscopy
tools, electrosurgery tools, guided catheters, glucose monitoring
devices, and a variety of high performance optical measurement
systems. His management experience includes taking eight
capital equipment development programs from concept to production
and establishing three manufacturing lines overseas.
Areas of emphasis include:
- A Holistic, Strategy-Based Design Methodology
- Design of Small, Complex, and High-Precision Mechanisms
- Machine Design
- Manufacturing Process Development, Implementation, and Qualification
Mr. Woodard is an alumnus of UC Davis (BSME) and Santa Clara
University (MSME).
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Scott Nierotka, Manufacturing
Manager
Mr. Nierotka has 15 years of manufacturing operations experience.
Recently, as an engineering consultant for a biotech company,
Scott worked on the design, development and manufacture of
drug delivery devices. He started his career in the medical
device industry as a manufacturing engineer and worked on disposable
vascular access products including needles, catheters, guidewires
and introducers. He has held positions of increasing responsibility
in both engineering and manufacturing operations. He has participated
in the design, development, pilot and final production of disposable
catheter based devices used for vascular access, infusion therapy,
EP mapping, RF ablation, as well as devices that enable patients
to better manage chronic conditions such as asthma, diabetes,
and hypertension.
Mr. Nierotka is a member of the American Production and Inventory
Control Society and is certified in production and inventory
management (CPIM). He holds a BS degree in engineering and management
from Clarkson University.
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Anthony Jones, Design
Transfer Manager
Anthony has more than 14 years of medical device experience
in a variety of roles in product development, operations and
engineering. He developed an extensive background in project
management, process validation, supply chain management, lean
manufacturing and design control. From 1994 to 2001 he
worked for Guidant Corporation, where he was responsible for
leading process improvement and manufacturing transfer teams
throughout the Guidant family of companies, with a primary focus
on increasing speed to market and reducing cost.
Most recently, Anthony worked for Cardica, J&J and PneumRx where he served
in roles with increasing levels of responsibility as Manufacturing Engineer,
Engineering Manager and Director of Operations. He has worked on a broad
range of products, including balloon angioplasty devices, cardiac surgery tools,
nitinol implantable devices, automatic anastomosis systems, COPD screening and
treatment devices, and blood glucose meters.
At Circle Medical, Anthony is responsible for developing manufacturing strategies
for new products and for successful transition of those products from the research
laboratory to the production floor.
Anthony holds a BS degree in Chemical Engineering from the Massachusetts Institute
of Technology, Cambridge, MA. In addition, he served 22 years in the United States
Air Force active duty and reserves, retiring at the rank of Lieutenant Colonel.
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Dana Lee, Quality
Systems Manager
Ms. Lee has spent the last 9 years in varying roles in
medical devices. She has worked for contract manufacturers
and product companies in such roles as: Materials Management,
Project Management, Operations Management and Quality Systems
Management, as well as I.T. support. Her broad experience
contributed to her leading projects on Product Commercialization,
Quality Systems implementation, MRP Software Implementation,
and IT Network and Phone Implementation. The Quality
Systems that she has implemented and maintained have received
ISO 13485:2003 and ISO 9001:2000 and FDB site certifications. Dana
is a Certified ISO 13485:2003 Internal Auditor by BSI, Inc.
Ms. Lee holds a Bachelor of Science in Business Information
Systems from the University of Phoenix.
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Rick Stephenson, Quality Manager
Rick has a broad range of mechanical engineering and quality
systems experience in aerospace, agricultural equipment, proteomics
research and medical devices. He spent four years as
a mechanical test engineer for the Stanford University/NASA
experimental physics project, Gravity Probe-B (GP-B). After
the successful launch of the GP-B satellite, Rick moved from
aerospace to biotech, where he performed verification and software
testing and field service for a biology instrumentation company
involved in proteomics. He also authored a new service
manual, led service engineer training classes, and was involved
in internal auditing for ISO and GMP compliance activities.
Rick has since worked as a quality engineer in the medical device industry and
earned his ASQ Quality Engineering Certification (ASQ CQE).
Mr. Stephenson holds a Bachelor’s of Science Degree
in Mechanical Engineering from Stanford University.
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Fred Dormishian,
Supply Chain Manager
Fred has more than twenty five years in various aspects of manufacturing
engineering, and supply chain management with high tech companies
including Apple, AMD, Xerox, MCE and contract manufacturing companies
including Solectron and Sanmina-SCI. He also has medical
device experience working at Aesculap Surgical Instruments. Fred
has held a number of senior management positions including GM
and VP of Operations at Sanmina-SCI, Global Director of Supply
Chain Management at MCE, and North America’s Senior Material
Operations Manager at Solectron.
He has aggressively reduced the cost of materials and operations
by leading global projects in sourcing, logistics, plant integration,
automation, acquisitions, product transfer and end-to-end continuous
flow supply chain management. Fred has designed and implemented
number of state of the factories such as Xerox and point of use,
JIT and Kan Ban systems. He has also implemented BAAN, Oracle
11i, Agile and a paperless, RF based WMS, inventory control and
material management systems to manage 35,000 SKUs in a high paced
environment within FDA guidelines.
Mr. Dormishian holds a BS degree in Industrial and Systems Engineering
from San Jose State University, and is completing an MBA from
University of Phoenix.
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Jianzhi Liu, Sr.
Electronics Engineer
Jianzhi has 7 years of experience in medical device design and
development. His experience includes analog, mixed-signal hardware
design, schematics and PCB layout, and embedded firmware programming.
He has held previous positions with St. Jude Medical CRMD, Alexza
Pharmaceuticals, and Neurotronics Inc.
Mr. Liu received his B.S.
degree in Mechanical Engineering from Shandong University of
Technology in China, and his M.S. degree in Electrical and Computer
Engineering from the University of Florida.
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Daniel Garcia-Denson, Quality Engineer
Mr. Garcia has over fourteen years of experience as a Manufacturing
Engineer working with medical devices and in other high technology
and biotechnology industries. At Circle Medical Devices, Mr.
Garcia‘s responsibilities have included testing and creating
test protocols for medical devices, documentation for clinical
builds, creation of medical device user manuals, and managing
maintenance and procurement of specialized instrumentation. Prior
to Circle Medical Devices, Mr. Garcia worked in roles of Manufacturing,
Process, Equipment, and Field Service Engineer, at high technology
companies Affymetrix, National Semiconductor, LSI Logic and Canon
U.S.A. He has participated in the development and implementation
of new manufacturing equipment, developing maintenance, operations,
troubleshooting, and training documentation, improving equipment
reliability, solving manufacturing and yield challenges, as well
as validation of equipment and process changes.
Mr. Garcia is a graduate of San Jose
State University with a Bachelor of Science Degree in Electrical
Engineering.
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Luis Baez, Mechanical Engineer
Mr. Baez has 3 years of experience in medical device development
and manufacturing. His experience comes from work on a broad
range of devices including intravascular ultrasound imaging
systems, OCT imaging systems, minimally invasive GI devices,
and cardiovascular catheters. His areas of expertise
include:
- R&D testing and design
- Laser welding process development
- Manufacturing process development
- Verification and validation
- Fixture design and fabrication
At San Jose State, Luis led a team in an opto-mechanical design
project in cooperation with FoxHollow Technologies.
Mr. Baez
is EIT certified and has a B.S. degree in Mechanical Engineering
from San Jose State University.
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James Walton, Senior
R&D Model Maker
Mr. Walton has more than 20 years of prototyping
experience in the medical device and pharmaceutical industries.
His professional career began at Syntex Pharmaceuticals manufacturing
unique R&D
equipment. He then spent seven years with Molecular Devices
prototyping the SpectraMax Micro plate reader platforms and Microphysimeter.
At Caliper Life Sciences, he helped to develop the company's
in-house prototyping capabilities to aid in the development of
a Lab-On-Chip Drug Discovery System. Mr. Walton's expertise is
in precision manual and CNC milling and turning, mechanical design
and materials.
Mr. Walton has an Airframe & Powerplant certification
from the Federal Aviation Administration.
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Ying Yang, Senior
Chemist
Ms. Yang’s experience includes physico-chemical characterization
of small molecules, peptides, antibodies and proteins by modern
analytical techniques, formulation of peptide and small molecule
drugs, clean-room manufacturing, assay development and validation,
as well as quality control under cGMP. She has worked
in the pharmaceutical industry developing both novel drugs
and novel drug delivery systems.
Ms. Yang received her B.S. degree in chemistry from Nanjing
University, China, and Ph.D. in Chemistry from Oregon State University.
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Sherry Zhang, Chemist
Ms. Zhang has worked on a wide range of projects including
development of advanced high power lithium-ion batteries, project
lead by the US department of Energy and the three US car companies,
characterization of polymer and drug delivery system for Dow
Chemical Company, studies on biological or biomaterials specimens
such as environmental biofilms, development of analytical apparatus
including the In-situ electrochemical cell for scanning transmission
X-ray microscope at the beam line 5.3.2 at the Lawrence Berkeley
National Lab, quantum chemical modeling of electrolyte reduction
and oxidation mechanisms, and development of nano composites.
Ms. Zhang received her B.S. degree in both Chemistry and Mathematics
from Eastern Oregon University, and Ph.D. in Chemistry from Oregon
State University. She then did her postdoctoral at the Lawrence
Berkeley National Lab.
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Colin Tan, System
Engineer
Mr. Tan is a biomedical system engineer with four years of
experience in the product design and development of medical
devices. His experience includes taking projects from concept
and design through to clinical trials and manufacturing. He
has managed and worked on a diverse range of projects from
tissue engineering of vascular substitutes to ocular implants,
glucose monitoring, orthopedic, and cardiovascular products. In
addition to ocular implants, Mr. Tan worked with the biomedical
engineering group at ALZA/JNJ on their new ocular drug delivery
and imaging technologies. Mr. Tan also has experience in business
development with the biomedical division at the Economic Development
Board in Singapore.
Mr. Tan received his B.S. degree in Biomedical Engineering
from Northwestern University and his M.S. degree in Bioengineering
from Stanford University.
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Katherine Stephenson, Mechanical
Engineer
Ms. Stephenson’s professional experience includes precision
jig design, opto-mechanical systems and glucose monitoring
devices. Her graduate work included orthopedics, musculoskeletal
development, surgical devices, high precision machining and
Autism management. As a result of her graduate work, Ms. Stephenson
has two patent applications in Orthopedic Surgery. She is also
a volunteer coach and manager of a martial arts program for
children with a wide range of physical and developmental delays.
Ms. Stephenson has a B.S. in Product Design and an M.S. in Biomechanical
Engineering from Stanford University.
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Ruth Costa, Project
Engineer
Ms. Costa is a recent graduate of Stanford University where
her Masters work focused on the design of electromechanical
systems. Specifically, she worked on coordinating hardware,
sensors, electronics, and software to create “smart” products. In
addition, Ms. Costa has experience in dynamic systems analysis
for the Aerospace industry.
Ms. Costa has a B.S. degree in Mechanical Engineering and an
M.S. degree in Mechanical Engineering from Stanford University.
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Asheesh Divetia, Biomedical
Engineer
Dr. Divetia is a biomedical engineer with experience in research
and development of implantable medical devices. He has worked
with the Diabetes division at Medtronic on the development of
implantable glucose sensors. He also has experience with development
of micro-electro-mechanical systems (MEMS), thin films processing
and integration of polymers with traditional micro-fabrication
techniques. His doctoral dissertation focused on the development
of implantable and self-regulated drug delivery systems. He has
authored several peer-reviewed technical papers and holds a patent
application for a novel drug delivery system.
Dr. Divetia holds a
M.S. and a Ph.D. in Biomedical Engineering from University of
California, Irvine and a BSEE from Indian Institute of Technology,
Bombay.
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Helene Pradhan, Senior Mechanical
Engineer
Helene has more than a decade of engineering and project
management experience in high technology and medical devices. Her
areas of technical emphasis include test and fixture design,
automation design, manufacturing process development, technical
writing, and statistical analysis. Her project management
experience includes leading the development of four different
overseas manufacturing lines.
Helene holds a BSME from Stanford University and is completing an MBA at San
Francisco State University.
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Phong T. Chau, Mechanical
Engineer
Mr. Chau has 1 year of experience in medical device development
and manufacturing. He has been involved with manufacturing process
development, verification and validation, fixture design and
fabrication, and design of experiments. At UCSD, Phong worked
in the Microhemodynamic and Microbiology laboratories After graduation,
Phong worked in the Pharmaceutical industry prior joining Circle
Medical.
Mr. Chau has a BS in BioEngineering with a minor in mathematics
from the University of California, San Diego.
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Shuo-Hsiu (Sosho) Chang, Mechanical
Engineer
Mr. Chang is a recent graduate from UC Berkeley. As an intern
in Hospira’s R&D department, Mr. Chang characterized
and developed a line of drug delivery systems, and at the UCSF
Orthopedic Surgery Lab he analyzed the fracture characteristics
of human vertebrae. In addition, Mr. Chang has industry experience
in fluid flow analysis for the power generation industry, and
research experience developing automotive oils at UC Berkeley’s
Surface Mechanics Tribology Lab.
Mr. Chang has a
B.S. in Mechanical Engineering and Materials Science Engineering
from the University of California, Berkeley.
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ZiHan Lin, Systems Engineer
Zi is a recent graduate
from Stanford University. As a student, he was involved in
various medical device projects - insulin inhaler, rhinoplasty
nasal retainer, and measurement of stent mal-apposition. His
research areas include neural stem cells and ablation catheters.
He also provided engineering support as R&D intern at FoxHollow Technologies and as R&D
mechanical engineer at ForSight Labs.
Mr. Lin has a M.S. in Mechanical Engineering with a concentration
in Biomedical Devices and a B.S. in Biomechanical Engineering
from Stanford University.
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Michael Yoon, Industrial
Designer
Mr. Yoon is an industrial designer
whose experience ranges from designing consumer electronic
products to living habitats for NASA’s
conceptual projects. His graduate work focused on designing personal
medical products which included a home ultrasound system, an
emergency water desalinization system, and a line of hybrid wheelchairs.
Mr.
Yoon has a B.S. in Mechanical Engineering from the University
of Rochester, and an M.F.A. from the Academy of Art University
in San Francisco.
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