Senior consultant with more than 30 year of experience in medical and other electronics. Experience with larger companies such as Advanced Technology Laboratories, Inc. (now Philips Medical), mid-sized companies such as EndoSonics Corporation (now Volcano Therapeutics, Inc.) and start-up businesses. Experience in corporate management with profit and loss responsibility, high volume lean manufacturing. Electronic circuit design, EMC, FDA, EC, UL, RTCA and other compliance matters.
Cameron Park, CA, U.S.A.
Advice and redesign: Electronic circuits, mainly analog, mixed signal and high speed digital. Advice related to electro-magnetic interference, electrical safety, agency compliance matters and the improvement of existing electronic circuitry which is not operating reliably or poses challenges in production. The emphasis is on educating client's staff, guiding redesigns or difficult new designs and enabling client's engineers to achieve improved results on their own with future projects. Recent projects include medical stimulators, battery operated medical gear, high-power ultrasound, laser wavelength locking, aircraft electronics, oil/gas industry, time domain reflectometers, DO-160 and EN60601.
1998 - 2001 Vice President and General Manager, Imaging Division
Rancho Cordova, CA, U.S.A.
Directed and coordinated all operations of the Imaging Division with approximately 100 employees. This included R&D, production of miniature disposable electronic ultrasound scanners, electronic systems production and materials management. Full P&L responsibility for the division. EndoSonics was acquired by Jomed, later by Volcano Therapeutics.
Mainline products: In-Vision IVUS system, Avanar Five-64 catheter scanner, PV8.2F catheter, WaveMap system, FloMap system. Core challenges were to dice and auto-assemble parts to a precision beyond industry standards and to reduce costs in the production process for disposables. Company merged with Jomed, Inc. and later into Volcano Therapeutics, Inc.
1996 - 1998 Vice President and Chief Technical Officer
MicroSound Corporation (100% subsidiary of EndoSonics)
Rancho Cordova and El Dorado Hills, CA, U.S.A.
Founded MicroSound on ideas outlined in a proposal. R&D and prototype manufacturing of a side-looking linear array integrated into a small flexible catheter and a PC-integrated ultrasound scanner. The array featured the world's smallest 64-channel active high voltage RF multiplexer in a single integrated circuit, an IC design on an automotive process.
Designed and contracted out the construction of a production facility with clean room which was ready for move-in by June 1998. However, a BoD decision split the corporate owner, EndoSonics, into three divisions and merged MicroSound into the new Imaging Division.
1989 - 1996 Consultant
Dipl.-Ing. Joerg Schulze-Clewing, Ingenieurbuero
Conducted research and development as an independent consultant to manufacturers of medical and other electronics. Operated own laboratory and shielded room for EMC pre-compliance tests. Consulting work included the design, manufacturing, standardization, and the regulatory agency procedures and requirements involved in bringing medical electronic devices to market. Among the projects completed were: Beamformer circuitry for several ultrasound scanners; diagnosis, modification and resubmission of biomedical equipment that had previously failed EMI compliance tests, failed to comply with U.S. FDA regulations, or violated VDE, UL or CSA safety regulations for electrical products; and assisting a Dutch medical equipment manufacturer to achieve ISO9000 certification.
Also developed equipment for Radar purposes, industrial control and measurement, optical speed measurement for traffic law enforcement, aircraft EMI improvement etc.
1986 - 1989 Research Engineer/Hardware Engineering Manager
Advanced Technology Laboratories
Solingen, Germany and Bothell, WA, U.S.A.
Developed analog and digital modules, including hybrid circuitry on thick film ceramic substrate with active laser trimming, for a new digital ultrasound beamformer. Became Hardware Engineering Manager in 1989. Major tasks: Amplifier, MUX and ADC design, high-speed digital design, IEC601 and UL544 safety and regulatory agency approvals for the UM5 ultrasound system and the Digidop digital blood flow analyzer. Also responsible for EMI compliance and certification of other ATL product lines at headquarters in Bothell, WA, U.S.A. German branch was closed and projects transferred to headquarters in 1989.
Aachen University, Aachen, Germany Dipl.Ing. (M.S.E.E.) 1986
Member IEEE, VDE
Languages English, German, Dutch (basic).