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Online Resumes with "IEC 60601"
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..
Highly motivated professional with leadership experience across verticals in regulatory compliance responsibilities. Recognized for excellence in search and planning for applicable worldwide regulatory standards for NPI/NPD. Self-starter, versatile, problem solver, and have willingness to work as part of a team. Forward thinker with demonstrated ability to lead and manage multinational cross-functional teams, analyze comple...
Tags for this Online Resume: Test, Troubleshooting, UL, Test Plan, Video, Wireless, Compliance, Consumer Products, EMC, Leadership, Energy Efficiency Compliance, REACH, EMI, EMC, HIRF, Lightning, ESD, Electrical safety, UL, wireless, Test Plan, Control Plan
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: * Around 7 years of experience in Software Testing in Web based Application, Insurance, Healthcare and Banking Applications. * Proficiency in defining, formatting and executing Test Cases based on Business Requirements Ensuring the Traceability for the requirements throughout the testing process. * Good knowledge with Medial Devices (such as ISO13485 standards, IEC60601, FDA processes such as PMA, 510k, Validation ...
SUMMARY: Hands-on, Multidisciplinary Design Engineer with Project Management and NPI/NPD experience. Electrical, Mechanical, Electromechanical, Controls, Process, and Lean Manufacturing Systems Design, Development, Commissioning and Optimization. * Purpose Built Machinery Design, Development, and Automation for Manufacturing, Assembly, Packaging and Test. Design Specification to Installation and Commissioning, IQ/OQ/PQ (Pro...
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
Areas of Expertise: * Design for Serviceability * Design for IEC 60601 EMC COMPLIANCE * Design for IEC 60601 SAFETY Compliance * Design for Manufacturability * TRANSITION OF PROTOTYPE DESIGNS TO MANUFACTURING * Analog, Digital & Power Circuit Design * 21 CFR 820 * PCB DESIGN * Research * Hands-on Prototypes * Cross-Functional Teams * ENGINEERING PERSONNEL MANAGEMENT * ISO 9001 * CLASS II AND III MEDICAL DEVICES
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.
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