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.

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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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

Chuck has 30 years of experience in product development, specializing during the past 9 years in the design and development of medical devices. His medical device experience includes an extensive range of devices including catheter control devices, standard x-ray and mammography systems, ablation systems, 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 IFUs and labels, and in the development of packaging for sterile, single-use devices and durable devices. Chuck 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, Sr. Project Manager & Mechanical Engineer

Mr. Jones has brought creativity and organization to product development and mechanical design engineering for eight years.  His engineering experience is focused in minimally invasive systems and ranges from proof of concept prototype design and creation to life testing, problem diagnosis and redesign of production units. Adam’s leadership experience includes directing multiple cross functional development teams of mechanical, electrical, biomedical and software engineers and technicians for domestic and international clients. He has participated in and directed projects including an automated catheter based cardiac aspiration system, a catheter delivery system for a left ventricle pacing implant and a point-of-care diagnostic instrument with consumable.

Before engaging in medical devices design, Mr. Jones taught Math and Science in California public schools for six years including service as Math Department Chairperson.

Mr. Jones holds a MS in Mechanical Engineering and MBA from California Polytechnic State University, SLO. His teaching credential in Math and Economics was earned from UC Berkeley graduate school of Education, and his BA in Business Economics was attained at UC Santa Barbara. All degrees awarded with honors.

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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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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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Ken Dilbeck, Senior Program Manager

Ken brings over 15 years of experience in designing, developing, and manufacturing medical devices and diagnostic instrumentation to the Circle Medical team, having developed a variety of products from medical centrifuges to blood glucose meters. Ken’s extensive knowledge of bringing products from conception to market comes from roles including Project Management in New Business Development of ODM (Original Design Manufacturer) Engineering Services at Wind River and managing a satellite Engineering Services department at Venture Design - a top ten contract ODM and overseas manufacturing company.  At Venture, Ken was the listed US FDA Agent, and led the corporate wide efforts in a new medical focused business strategy. Prior to Venture, he worked on the development of medical laser systems at a medical device startup company that recruited him from Beckman-Coulter, where he had worked in product development for over 10 years developing a variety of life sciences and diagnostic instrumentation.

Mr. Dilbeck holds a Bachelor of Science degree from the University of Phoenix, Arizona and has completed professional project management courses towards a Masters Certificate.

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Betsy Gutierrez, Quality Systems Manager

Betsy has over 8 years of leadership experience in both Quality and Operations roles within the Medical Device Industry.  Throughout her career she gained a broad Compliance background and extensive auditing experience.  She has managed multiple design transfer projects and several international product line transfers.   Betsy also has extensive experience in managing and implementing Lean Manufacturing practices.  Prior to joining Circle Medical Devices, Ms. Gutierrez served as a QA consultant at Acclarent Inc. and as QA Manager at LuMend (a J&J company).  Before joining LuMend, Betsy served in a number of positions with increasing responsibility at Edwards Lifesciences, including Quality Section Manager, Engineering Section Manager and Supply Chain Manager. 

Ms. Gutierrez received her Bachelor’s degree in Industrial Engineering and an MBA from Pontificia Universidad Catolica Madre y Maestra in the Dominican Republic.

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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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Kirsten Luehrs, Project Manager

Kirsten has over 15 years of experience in the medical device industry.  She has held project management and mechanical design engineering positions at major corporations, including Johnson & Johnson, Medtronic and Westinghouse, as well as smaller and start-up companies including Fogarty Engineering, AneuRx and Nitinol Devices and Components.

To date, Kirsten is an inventor on 18 issued US patents, and 11 published US patent applications, which include stent grafts, stents, delivery catheters, sheaths and Nitinol wireform device innovations.  Product development experience and interest include various disease states, such as peripheral vascular, structural heart, urology, gynecology, neurology, general surgery and health care related consumer products.  She has experience in project management through schedule, budget and internal and external resource management, as well as experience in product development through clinical and client input, market research, hands on design, prototyping and testing.

Ms. Luehrs holds a BS in mechanical engineering from the University of Illinois, Urbana Champaign, a Product Design MS in engineering from Stanford University, and an MBA from the University of California, Berkeley.

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James Osborne, Senior Software Engineer

James has more than 20 years of experience developing hardware and software solutions for various industries including automotive, avionic and commercial.  James has worked on a broad range of projects from underground mine control systems to vehicle communications. James is familiar with all phases of the development process including hardware design, board layout, firmware creation and PC software application programming. James’ background includes intimate knowledge of embedded systems, Visual C++ MFC, various communication protocols and RTOS. Prior work includes RFID at Texas Instruments, OnStar, Vehicle systems at Delco Electronics, and Wireless communications.

Mr. Osborne holds a B.S.E.E from Southern Illinois University, Carbondale, IL., and a P.E. license, Kentucky.

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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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Abhishek Krishnamurthy, Embedded Software Engineer

Abhishek has 5 years of experience in embedded systems software engineering. He brings expertise in the area of multi-disciplinary testing from his work at Honeywell Inc. where he was involved in testing fiber optic gyroscope electronics and optical components. He has also worked in developing the full life-cycle development of new mobile products as part of the Howard Industries Group’s Computers Division. As a computer engineering graduate he was involved in developing embedded, real-time sensor data processing software for a prototype optical slip-ring application as part of a Physics research group funded by NASA. His experience also encompasses:

• Software testing and verification
• ASIC development
• VHDL and Verilog testing

Mr. Krishnamurthy has received a Bachelor of Science in Computer Engineering and a Master of Science in Computer Engineering from the University of Alabama in Huntsville.

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Howard Goodman, Buyer/Planner

Mr. Goodman has 10 years of experience in the Medical Device industry with a background in Quality Assurance and Product Development that enables him to ensure accurate and strategic procurement for medical device development.

Howard previously provided extensive engineering support for the development of Coronary Artery Bypass Graft [CABG] devices as well as Vessel Harvesting technology.  At Boston Scientific and Guidant Corporation, Howard developed and improved upon a broad range of R&D testing techniques for the HeartString Aortic Cutter program, ensuring high-quality results in beating heart clamp-less anastomoses.  He also provided Product Development and R&D support for Guidant’s VasoView Endoscopic Vessel Harvesting (EVH) product line for CABG procedures, and was involved in R&D, Lab Testing, and QA of additional product lines including the Acrobat V Vacuum Stabilizer, the XPose IV Positioning Device (for CABG procedures), and the HeartString II Proximal Seal System  for clamp-less hemostasis while suturing.  

Mr. Goodman holds a B.A. degree from California State University, Chico.

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Neha Shroff, Quality Engineer

Neha has over 2 years of experience in working with medical devices such as Ventilators, ECG Stress Test Machines, X-ray machines, Patient Monitoring Systems, Defibrillators, Infusion Pumps, Implantable Cardiac Devices, and Pulse Oximeters. At USC, Ms. Shroff specialized in Quality Systems (ISO 13485:2003 & 21 CFR 820), Regulatory Affairs for medical devices, and Structure and Management of Clinical Trials.

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, various minimally invasive GI devices, minimally invasive electrosurgical devices and cardiovascular catheters.  His areas of expertise include:

• R&D testing and design
• Electro-mechanical design
• Electrosurgical design
• Laser welding process development
• Manufacturing process development
• Verification and validation
• Fixture design and fabrication

Mr. Baez has a B.S. degree in Mechanical Engineering from San Jose State University and is EIT certified.

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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 has 12 years of experience in the medical device and pharmaceutical industries.  She was the key contributor in the development of a biodegradable ocular implant for glaucoma treatment.  She has experience in sterilization and sterilization validation, material selection, biocompatibility testing, cleaning, accelerated aging and packaging validation strategies for a variety of medical devices including heart valves, catheters, chemical sensors for emergency use, biopolymer ocular implants, and endo-surgical tools. Her extensive background in the pharmaceutical industry involved novel drug and drug delivery development from the R&D phase to Clinical Phase IV studies.  She has worked on modern instrumental analysis of pharmaceuticals (aerosol, liquid, and solid dosage), analytical method development and validation, formulation, clean-room manufacturing, as well as quality controls under cGMP.  Ms. Yang was a project manager at a major pharmaceutical company, leading the development of a top priority project. She was a key contributor to 1 European patent and 3 U.S. patents under filing.

Ms. Yang received her B.S. degree in Chemistry from Nanjing University, China, and Ph.D. in Analytical 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 has worked on a range of mechanical design problems for the medical device industry for the last five years, and designed opto-mechanical systems for the telecommunications industry for three years prior to that. Her projects have included several steerable cardiac catheters, long term cardiac implants, various devices for glucose monitoring, and orthopedic surgical tools. Her design experience covers the entire medical device package, from core device mechanisms to manufacturing fixtures to final packaging. In her spare time she is 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, Mechanical Engineer

Ms. Costa has worked for two years in the medical device industry, on devices including cardiovascular catheters, RF and mechanical GI catheters, and implantable cardiac devices.  She has experience in all phases of product development, from concept generation and prototyping through design verification testing and clinical build supervision.  Her engineering expertise includes mechanism design, electrosurgical design, laser weld process development, verification testing, and technical writing. 

Ms. Costa graduated from Stanford University with a B.S. degree in Mechanical Engineering and an M.S. degree in Mechanical Engineering with a focus on the design of electro-mechanical systems. 

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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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