
Ken Sumikawa PMP, CSM, ITIL®, SSYB, BSCS
Technical IT Project Manager/Software Engineer at University of California at Berkeley @ Livermore, California
R&D Director in a Medical device Company
Tzur Itzhak, Central
Career Objectives: R&D Manager, Project Manager.
Project Manager and motivated R&D engineer with strong academic background and more than 20 years of experience in high-tech companies.
Professional Summary:
• R&D engineer in High-Tech companies: 2000 - present
• Medical Devices: 2002 - present
• Optical engineering: 10 years
• Applied Electrodynamics & antennas: 4 years
Hands-on experience in:
R&D
• Medical device R&D Project Management;
• Design Control (FDA QSR)
• Risk Management (ISO 14971);
• Development of multidisciplinary systems: Optics, hardware software;
• Design of imaging optics, specifications of components and test methods.
Regulation
• EU MDR and FDA: DHF, Technical file, labeling, biocompatibility.
Up-to-date professional training, exceptional communication skills and proven leadership ability, strong technical intuition, troubleshooting and problem-solving skills.
Specialties: Research and Development, Medical device regulation, Design Control, Optics and Electro-optics.
Technical IT Project Manager/Software Engineer at University of California at Berkeley @ Livermore, California
Connecting 1s and 0s @ Los Angeles, California
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