Systems Engineering

Milan Trcka, Chief Technology Officer

Milan brings over 25 years of electronic and electromechanical system design and project engineering experience specializing in RF systems, wide-band instrumentation systems, analog and RF circuits, power electronics, analog, digital and RF PC board design and packaging. He has designed high-power, Class-D ultrasound ablation amplifiers and matching networks; variable-output switching power supplies; brushless, sensorless DC motor drivers and controls; portable high-capacity battery power management systems, low-level electro-chemistry and dynamic motion-sensing channels; systems using microprocessors and FPGAs; 2.4GHz digital radio applications, wireless modems, 25MHz wideband instrumentation systems, high-performance space-borne magnetic tape recorder systems, 250Mb/s low-error rate data channels, and RF filters and amplifiers. Milan is fluent in English and Czech. His papers have been published in Japan and by IEEE. He has two patents in magnetic recording and others pending. Milan holds a BSEE from University of Maryland and an MSEE from California State University, Los Angeles.

Electrical Engineering

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Olga Alayev, Director, Electrical Engineering

Olga has an extensive experience in design and development of electronic equipment. She is proficient in all areas of new product research, development, and design as well as manufacturing processes, material and component selection. Olga has managed product design from initial specification stage to the production release, which involved concept design, component selection, schematic and complex multi-layer PCB layout generation, firmware design and verification, mechanical design, BOM generation, product test and verification. She is highly proficient in embedded firmware design using C with experience in several microprocessor families. Olga holds Bachelor of Science (with honors) in Telecommunication Engineering from Tashkent State University of Electro-Technical Communication Engineering in Uzbekistan and an MBA from the University of Phoenix.

Randy Ponitzman, Senior Electrical Engineer

Randy has over 30 years of circuit design experience with expertise in the areas of digital design and programmable logic. He has designed digital circuitry ranging from designs with only SSI/LSI logic devices to designs using memory such as SRAM and SDRAM to large FPGA designs that he implemented using VHDL or Verilog. He has done designs using ADCs and DACs. He has developed systems using many different microprocessors including devices from Intel, Motorola, Cypress, AMD and Atmel. In his more than seven years at Aubrey Group he has developed electronics for a number of medical products. On one product he developed the digital control for the RF power delivery system for a heart ablation system. In another project he added an Ethernet interface. In addition to his expertise in VHDL and Verilog hardware design languages, he has developed software using C, C++ and assembly languages. He holds a BSEE degree (with honors) from the University of Florida.

Jeff Crockett, Senior Electrical Engineer

As an analog design engineer, Jeff has designed RF and analog circuits, atomic clocks, power supplies, EMC-compliant circuits, and low-power, low-noise DC-DC converters. Jeff began his 25 year engineering career in aerospace designing custom hybrid microcircuits. More recently, he has designed low-noise RF power oscillators, phase-locked loops, frequency synthesizers, precision temperature controllers, analog filters, and amplifiers. He has also developed precision closed-loop control algorithms and systems for atomic clocks. Jeff holds three patents in atomic frequency standards and has authored a poster paper on power supply noise at a 2002 IEEE symposium. He has a diploma from DeVry Institute of Technology.

Chris Ludolph, Electrical Engineer

Chris joined Aubrey Group after obtaining BS degree in Electrical Engineering from UCSD. He is heavily involved with the design of electronic circuitry in support of both front-end signal acquisition and processing and integration of FPGA and microprocessor elements into systems. His work has taken him into electromechanical design as well as testing of such designs. In addition to hardware design, he has developed important skills in the use of LabVIEW.

Kaity Schaefer, Electrical Engineer

Kaity graduated from Johns Hopkins University with a BS in Biomedical Engineering and Electrical Engineering, as well as minors in Robotics, Entrepreneurship and Management, and Mathematics. In her career, she has had experience with research, design, troubleshooting, and implementation of medical devices. She received first place in the Johns Hopkins University Honors Instrumentation Competition in 2011 for the invention and design of a TMJD Detection and Therapeutic Device. She is a certified EIT, Certified LabVIEW Developer, and Certified TestStand Developer. Her current work includes building and testing breadboards and text fixtures, electronic design and schematic capture, and design testing.

Software Engineering

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Sean Nash, Director, Software Engineering

During his 15-year career as a software engineer, Sean has developed software for surgical lasers, in-vitro diagnostics, pacemakers, ophthalmic devices, ablation systems, blood processors, intravenous body temperature controllers, patient monitors, home monitors, and infusion pumps. In addition, he has experience developing single and multi-user Windows software including design and development of an FDA-compliant medical device service and complaint-handling application, a manufacturing distribution supply chain management application, and a clinical trial data collection application. He is experienced in all phases of product development. He has experience with compliance to IEC 60601-1-8. He has worked with several real-time operating systems, including ThreadX and MicroC/OS-II and holds a BS in Information and Computer Science from the University of California, Irvine.

Jeffrey Beaupré, Senior Software Engineer

Jeffrey is a software engineering generalist, with experience in artificial intelligence, distributed applications, embedded devices, internet applications, operating systems, and database management software development in a variety of programming languages and platforms. He has applied best practices in software architecture, detailed design, and implementation to various command, control, and automated planning systems as they apply to unmanned aerial vehicles (UAV). Development projects include the RQ-8B Firescout, the RQ-4 Global Hawk, and the A-160 Hummingbird. A runner-up for the Viterbi School of Engineering Archimedes Award, Jeffrey graduated with honors, and at the top of his class, earning a BS in Computer Engineering and Computer Science from the University of Southern California.

Matthew Meyer, Senior Software Engineer

During his professional career, Matthew has developed software for the Boeing 747, database applications for the Space Shuttle, business and consumer credit database applications, and IEC 61508-compliant, triple-redundant IO systems for safety critical control of industrial processes. He has expertise in C, C++, and Ada, and with ARM-based processors. Matthew holds a BA in Mathematics from the University of San Diego and a MS in Chemical and Biochemical Engineering from the University of California, Irvine.

Brian Lau, Software Engineer

Brian began his career in Network-Attached Storage (NAS) device development where he designed and tested software modules on file system management while interfacing with Fibre Channel networks. In the aerospace industry, he developed and maintained safety-critical control software for a fly-by-wire rudder control system under FAA regulation (DO-178 Level A and B), and organized the software and requirements verification effort. In addition, he has experience in developing a military RF communication system from Datalink level to Application level. Well versed in C, C++, C#, Java, and Web development language such as Flash, Flex, ColdFusion and Javascript. He is also experienced in various software development models including CMMI. Brian holds a BS in Information and Computer Science from the University of California, Irvine.

Himanshu Patel, Software Consultant

Himanshu has over 10 years of product design experience with the last seven dedicated to medical devices. Prior to his joining Aubrey Group, he held various positions, including Project Engineer at Indian Space Research Organization, Software Engineer at Cisco Systems and Principal Software Engineer at Medtronic Inc, during which he has applied for 9 US patents in the field of glucose monitoring, wireless medical device communications and medical device innovations. He is experienced in all phases of product development, from concept to design, implementation, and verification. He has product design experience with various microcontrollers from Intel, Atmel, Hitachi, Motorola, Texas Instrument, Microchip as well as Custom ASIC, FPGA and CPLDs. He has extensive experience with several real-time operating systems, including ThreadX, Redhat eCos, Cisco IOS and various other custom OS. He has designed various custom wireless solutions for medical devices using Bluetooth, Zigbee and low power wireless protocols in ISM band. Himanshu holds a BS in Computer Science and Engineering from Bangalore University, India and MSEE candidate from California State University, Northridge.

Bill Welsh, Consultant, Software V&V Engineer

Bill has more than 25 years of design and management experience in product, software, and hardware development for military, commercial, and medical systems. He has over 7 years of specialized experience in the development of risk analyses, documentation, and software verification and validation protocols that meet FDA standards. He holds a BSEE from Purdue University and an MS in Computer Engineering from California State University, Fullerton. He is also a Novell CNE.

Mechanical Engineering

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Aaron Gifford, Director, Mechanical Engineering

Aaron has over 14 years of professional engineering experience in industries ranging from dry toner production, robotic assembly work cells and high-speed semiconductor manufacturing equipment, to implantable medical devices. He has extensive experience with both R&D and manufacturing, designing equipment and assemblies, as well as supporting tooling and fixtures. His achievements with semiconductor test equipment, capable of a controlled temperature range of -76°F to 320°F while testing and sorting IC’s, include: cost-reduction and feature-enhancement activities; design upgrades; pneumatics; electro-mechanical systems; servo systems; temperature measurement and control; and even field support in the Philippines. He developed custom robotic tooling for circuit board assembly for firms such as Chrysler and Delphi. He also developed a LIM molded implantable spinal cord stimulating lead for controlling pain and has a patent pending in this field. At Cal Poly, he earned a BS in mechanical engineering and worked on its Tournament of Roses Parade floats. His medical device experience at Aubrey Group includes a real-time blood glucose meter and design of an electrosurgical instrument for cauterizing and cutting tissue during surgery.

Thanh Nguyen, Senior Mechanical Designer

Thanh has over 20 years of experience in technical drafting. During the last 10 years, he has done many valve designs for high pressure coolant systems. He has created many prototypes, reversed-engineer and fixtures for the semi-conductor industries. He has also designed some medical devices for back bone surgery and dental tools. He has over 15 years of experience as an AutoCAD designer. He has a diploma at ITT College and also a Certified SolidWorks Professional.

Clark Foster, Mechanical Systems Engineer, Consulting Fellow

Clark brings over 25 years of mechanical engineering and system design experience in development of medical devices, production technology, and aeronautics. He is listed with the USPTO as a Prolific Inventor with 137 US utility patents from 1988 to 1997 (25th in the world). He has experience designing knee braces, medication inhalers, implanted artificial occluding muscle, safety syringes, blood draw and IV systems, surgical instruments, drug vials, and insulin injecting pens. He has designed production assembly tools for disposable pump cartridges and an intraocular lens centering arm trim machine. Clark has also worked on projects for space reentry vehicle surface cooling, jet engine location optimization, and the B2 Bomber wind tunnel. He has a private pilot’s license and is a certified assistant aerobatic judge. Clark holds a BSME from University of Washington.

Charles Clemens, Consultant, Senior Mechanical Engineer, Disposables Design

Chuck has over 25 years of hands-on biomedical disposable and device experience including IV fluid-delivery systems, DNA/SDA system development, blood-pressure monitoring systems, liquid drug inhalers, medical heat exchangers, disposable diagnostic devices, liquid biocompatible adhesive delivery, thermometry, and custom orthotics. He has developed manufacturing processes. Chuck has significant experience in the application of FDA, CGMP, GQR, and ISO regulations. He has worked both as a consultant and full-time staff member at start-up companies and large corporations. He was Technical Director for Development Engineering for Alaris Medical Systems (formerly IVAC). At Carbomedics, Inc. he was Project Manager for Process Development Engineering. He has also worked for Alliance Pharmaceuticals Corp., Mission Medical Inc., Becton Dickinson/Nanogen, Inc., JV, Prism Medical, AreoGen, Inc., and InJet Digital Aerosols. Chuck is an inventor on two U.S. and one Canadian patents and has patents pending. He has a BS degree in mechanical engineering from San Diego State University.

Aileen Huynh, Mechanical Engineer

Aileen graduated from UC Irvine with a BS in Mechanical Engineering with a minor in material science. Her experiences ranges from involvement in UCI Racecar Engineering, where she was involved in designing, fabricating, and testing of student-built, performance racecars that competes in FSAE and other local competitions, to researching on the feasibility of producing a tough, lightweight, shape formable multiphase ceramic for armor application through processing and analysis of the ceramic composite. Her current work involves designing, developing, and testing of mechanical assemblies and components. She is also involved in creating and reviewing technical drawings as well as some fabrication, operation, and troubleshooting of mechanical devices.

Manufacturing and Support

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Hyung Kim, Director of Manufacturing

Hyung has over 20 years experience in Medical Device industry. He has a very diverse background, with experience in Manufacturing, Manufacturing Engineering, Mechanical Engineering, and Quality Engineering. He has primarily supported Manufacturing and Design Transfer activities including process and fixture development, complaint investigation, CAPA and problem solving, risk analysis, and design and process improvements. Hyung is experienced with various medical devices including infusion pumps, patient monitoring devices, ECG recorders and holter monitors, and cryosurgical equipment. Hyung holds a BSME through Kettering University; certifications as a CQE (Certified Quality Engineer), CQA (Certified Quality Auditor), and CBA (Certified Biomedical Auditor) through ASQ (American Society for Quality); Six Sigma Black Belt through UCSD Extension; and Lean Manufacturing through SDSU Extension.

Sharee Fox, Buyer and Planner, Component Specialist

Sharee has over 30 years experience in manufacturing, planning, and component engineering. Her past experiences range from procurement and component engineering at a very small NPI facility, to manufacturing and component engineering responsibilities at large printer/plotter, computer, and in-flight entertainment manufacturers in Orange County.

Electronics and Mechanical Assembly and Technical Support

We have six assembler/technicians. Our electronics assemblers are experienced in the manufacture of surface mount printed circuit boards and cable and wire harness designs, surface mount and thru-hole techniques, and in-process quality inspection during PCB assembly. Several are extremely capable in the detailed rework of fine pitch devices like FPGA’s. Our mechanical assemblers build, test, and re-work assemblies, test, and document test results. All do troubleshooting and are trained in GMP and ISO 9002 compliance in PCB assembly.

Quality Assurance

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Grant Palmer, Vice President, Regulatory and Quality

Grant has over 20 years of experience in the design, development, approval and manufacture of medical devices. He has formulated successful regulatory strategies and submissions for innovative Class II and Class III devices, as well as developed and maintained compliant medical device quality systems. Grant has also designed medical devices from the concept stage and managed development through clinical studies, regulatory approval and manufacturing transfer. His expertise spans across a diverse range of medical devices, including disposables, permanent implants and external equipment covering cardiology, interventional radiology, ophthalmology, oncology, nephrology and general surgery. Before joining Aubrey Group, Grant held senior positions at both small and large medical device companies, including Boston Scientific and Baxter. Grant holds degrees in Electrical Engineering, Computer Science and Physics from the University of Sydney, Australia.

Paula Lam, Quality Control Technician

Paula has over 14 years experience working in the Manufacturing and Quality Control of Photonic and Laser Optical Devices used for Research & Development, Medical, and Military Industries. She built laser and optical miniature devices then later worked as an inspector in the field. She is also a certified Pharmacy Technician. She has experience with ISO 9000 and 5 S principles, helpful in the efficient handling of quality and manufacturing processes.

Steve Clark, Quality Engineer

Steve is a medical device industry professional with over 25 years of experience. He has contributed his engineering talents to a wide range of industry-leading companies including Edwards Laboratories (Lifesciences), Baxter, Applied Medical, Sakura Finetek, Terumo CVS, and CooperSurgical/SAGE IVF. Steve’s experience spans a wide range of products, including formulated/aseptically-filled In-Vitro Fertilization (IVF) media, cleanroom-assembled and post-sterilized consumable and reusable medical devices and instruments (e.g., laparoscopy, histology, heart monitoring, vascular surgery, urology), cardiovascular surgery devices and monitors, and various types of electromechanical laboratory instruments. Steve has held varied engineering discipline positions ranging from Industrial, Manufacturing, Quality and Project Engineering, in addition to senior-level Management and Operations positions in both larger company and startup-company environments. He has previously consulted internationally, focusing on Quality Management Systems, QMS improvement and Auditing. He has trained in both internal and external auditing to ISO standards and served as company Management Representative and hosted various notified-body audits and Federal FDA inspections.
Steve holds a B.S. degree in Industrial Technology from San Diego State University, an MBA from the University of Phoenix, and has subsequently completed all courses for Six Sigma Green Belt and Green Belt Plus.

Business Development, Finance, and Administration

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Sean O’Campo, Director Business Development, Southern Region

Sean brings more than 17 years experience in technical sales and service. He possesses a very strong understanding of regulatory compliance which was gained during his employment at Intertek Testing and Underwriters Laboratories. Throughout his career he has held various Senior Account Executive and Management positions. Most recently, he was Director of Business Development at HDA Technology, a Medical Device Development firm located in Southern California. He holds a degree from DeVry Institute of Technology.

Rick Cameron, Director Business Development, Northern Region

Rick brings more than 25 years experience in contract development and manufacturing sales. With a background in mechanical engineering, Rick has medical device and lab instrumentation experience. He is a native of the Bay area and has successfully done sales for companies in Silicon Valley and the San Francisco Bay area.

Cindy Harman, Controller

Cindy has over 20 years of accounting and financial management experience. Prior to joining Aubrey Group in 2005, she was a self-employed consultant; primarily of counsel in accounting and general business matters, and implementation of internal controls to include strategic financial planning and analysis, accounting department management, and the overseeing soundness of financial reporting and planning. She holds a BS in Accounting from the University of Phoenix.