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Online Resumes with "IEC 60601"
Director of New Product Development, Regulatory Compliance & Finished Product Fabrication
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..
Tags for this Online Resume: Medical Device Certification, IEC-60601-1 3rd Ed, GMP - IS0 14384 , Medical products manufacturing, lean principles , product development manager , EMC Design Engineer
Engineering Manager - 20 Years of Experience - Near 60089
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
Electrical Engineer - 20 Years of Experience - Near 66216
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
Quality Assurance Specialist - 7 Years of Experience - Near 55446
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 ...
Tags for this Online Resume: Java Programming Language, Test, Test Cases, Microsoft Windows, Structured Query Language, Management, Regression Testing, Test Plans, Acceptance Testing, Agile, sql
Engineer - 20 Years of Experience
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...
Tags for this Online Resume: Electronics, Control Systems, Manufacturing, NEC, Power Distribution, Reliability, Troubleshooting, UL, IEC 60601, Systems Design
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
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...
Ideal Companies: A company with suability, growth and development of their employees.
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
Electronics Engineer - 20 Years of Experience - Near 30054
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
Tags for this Online Resume: Rf, Compliance, EMC, System design, Analog Design, Electronics, Magnetic Resonance Imaging (MRI), Research, Networking, Product Development
Electronics Engineer
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...
Ideal Companies: Aerotek, Raytheon, Eaton
Tags for this Online Resume: Biomedical Industry, CCS, Debugging, Documentation, Ideal, ISO, Packaging, Python Programming Language, Schematics, Security
Engineering Technician - 17 Years of Experience - Near 55411
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.
Tags for this Online Resume: Engineering, Medical, EMC, ISO, Telecommunications, ANSI, Ansi (Am Natl Stds Inst), Manufacturing, Quality, Quality Assurance
Clinical Regulatory Affairs - 20 Years of Experience - Near 80023
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
