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Online Resumes with "60601 1"
Senior management involved in medical device development, manufacturing & installation with direct responsibilities involving product fabrication, regulatory certification and medical quality systems for compliance under the IEC 60601-1 (3rd Edition) Medical Devise Standard..
Skilled engineer with 20+ years of experience in the areas of various fields of electronic systems, analog and digital electronics, instrumentation, testing, prototyping, calibration and diagnostic equipment (oscilloscopes, DMM, signal generators and specialized test apparatus incl. microscopes), DC/DC converters, DC Motor Controllers, switching power supplies, low power RF technology. Creating BOM’s, reading and interpreti...
SUMMARY * More than 30 years of professional experience and progressive accomplishments in leading design, development, research, test, improving design and producing high reliable electrical & electronics circuits, components, systems, subsystems, customer service, and engineering practices with IEC 60601-1, FDA, ICE, UL, CE, FAA, FCC, Mil. Std. 461/DO-160 and DO-178/254 * Energetic self-starter, creative thinker, able to ...
Tags for this Online Resume: Firmware, Amplifier, C Programming Language, Integrate, Circuit Design, Test, Automatic Test Equipment, C++ Programming Language, C/C++ Programming Languages, Layout, electrical engineer
SUMMARY A professional Quality Control and Quality Assurance Engineer/Specialist with 9 years of experience implementing and improving quality management systems/ programs to support Manufacturing, instrumentation, Validation, and processes Quality Management Systems and Information Management Systems Qualification Summary: Quality Assurance (manufacturing) * Experienced in ISO 9001 and ISO 13485 standards to ensure that pr...
PROFESSIONAL SUMMARY o Prioritizing and multitasking as and where necessary in fast paced startup along with hands on experience in production line. o Experience in characterizing the antenna and tune it with the matching network elements. o Good experience in IEC 60601-1, IEC 60601-2-25, IEC 60601-2-47 for FDA flow, and ISO standard. o Hands on knowledge in setting up new evaluation modules as per requirement. Ability to r...
Summary Accomplished Engineering Technician with experiences. Proven skills in processing, manufacturing, troubleshooting, quality testing and failure analysis of PCB. Solid knowledge of CEI/IEC 60601-1-2 Medical ANSI/ISO standards and GMP requirements. US patent for SLA coating process. Proficient in Microsoft Office Products. Fluent in English, French, Laotian and Thai.
Searching a position as senior/principal quality, manufacturing, R&D engineer focused in mitigation, remediation, redesign and process change for cost savings and product quality enhancement, CAPA initiation and execution, and new product development.
Ideal Companies: medical or Aerospace industries
Tags for this Online Resume: Manufacturing, Medical Devices, Product Development, Research and Development, R&D, IQ/OQ/PQ, Pfmea, Dfmea, Certified Quality Auditor, Six Sigma/ Lean Sigma Green Belt, Quality Foundation Deployment Green Belt, MiniTab, Managing Cross Functional Teams, Solid Works Design, Conceptual Design, New Product Development, Risk Analysis, Negotiations, Customer Relations, Value Engineering, Decrease Field Failure, Increase Customer Satisfaction, Report writing, Authoring and enhancing Standard Operating Procedure, ISO 13485, ISO 14971, ISO 60601-1, Authoring Quality Manual, Design Validation, Verification, Valves, Switches, Linkages and mechanism design and development, Complaint Handling
SUMMARY OF PROFESSIONAL EXPERIENCE Regulatory, Quality, Clinical and Compliance Medical Executive with major milestones/achievements in the Life Science Industry. Over 30 years in Class III and Class II devices/allograft/biologics, inside/outside the United States (OUS) primarily in the fields of cardiology, cardiovascular, neurology, spine and orthopedics. Integral involvement with 80+ product categories. Personally prepar...
Tags for this Online Resume: Medical Device, Regulatory/Quality, Clinical, Audit, Distribution, Budgeting, Microsoft Windows CE, Advertising, Cardiovascular, Compliance, clinical, trial, protocol, ich, FIM, EFS, gcp