CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "CE Markings"

Safety Manager - 20 Years of Experience - Near 40475

Skills Summary * 15 years of product certification experience managing agency projects with multiple agency partners. * Review of proposed IECEE/CE Regulatory standards for US Tag for TC61. * Experience facilitating compliance with CE marking directives. * Development of compliance team and certification related processes. * 10 years' experience handling commercial cooking, commercial refrigerator and other related categori...

Tags for this Online Resume: Program Manager, Certified Senior Advisor, EMC, Packaging, UL, Management, 5S, ASTM, Compliance, ISO

Medical Scientist - 13 Years of Experience - Near 95035

SUMMARY: Accomplished management of two (2) CE Marked& IDE approved drug combination medical devices from concept. Co-creator and developer of the Stellarex Drug Coated Balloon (DCB) and Chocolate Touch DCB angioplasty systems. Multi-level, inter disciplinary management from start-up phase to acquisition with hands on R&D, preclinical and clinical regulatory experience. Institutionally trained in general, obstetric and vasc...

Tags for this Online Resume: Manufacturing, Critical Care - Vascular, Engineering, Process Engineering, Surgery, Business Development, Functional Testing, Instrumentation, pharmacology, medical device

Electrical Engineer - 12 Years of Experience - Near 53189

Electronic design hardware and software development serial data networks PCB layout PSPICE simulation controls design relay logic PLC programming wiring diagrams ladder diagrams sizing motor starters sizing transformers cabinet layout small bracket design developing test strategies and procedures production test validation test (EMC electrical transients vibration environmental) fixture design drafting writing test reports ...

Tags for this Online Resume: AutoLISP, PLCs, Drafting, electronic design, C, Software Development, Troubleshooting, Autocad, controls, PCB layout, embedded controls, hardware design

Biomedical Engineer - 19 Years of Experience - Near 84092

Qualifications include: 19 years experience in medical device/pharma fields. 7 years experience in other industries including semiconductor mfg. and marine engineering. Team member of 3 successful medical device companies through start-up, acquisition and integration. Broad experience operating a medical device business to include: R&D, engineering, manufacturing, regulatory, QAQC, operations, finance, and sales and marketi...

Tags for this Online Resume: Medical Device, Emergency Medicine, Surgical, Engineering, Research and Development, Medical Devices, Regulatory, Qualify assurance, Manufacturing

Market Research Analyst - 15 Years of Experience - Near 33408

SUMMARY High performance, proven results-driven C-level Global Marketing and Sales Manager with 15+ years leading marketing, sales forces and cross-functional new product development, new product introductions and market launch teams generating $438 Million global sales growth for leading medical device manufacturers: Baxter, Atrium Medical, Allegiance, Bayer, Cooper Vision, Pilkington Vision Care, BioElectronics and Surgif...

Tags for this Online Resume: Banking Industry, C Programming Language, Cardiovascular, Catheter, Chemistry, Citrix, Critical Care - Vascular, Customer Relationship Management, Distribution, EKG

Health Technologist - 0 Years of Experience - Near 11746

SUMMARY Senior Quality and Regulatory professional experienced in high tech and medical device manufacturing industries. Progressive responsibilities in all areas of Quality Systems in the implementation of TQM, SPC, Six- Sigma, re-engineering, Continuous Improvement, Quality function deployment, implementation of FDA-GMP or QSR, ISO-9001, EN-46001, ISO 13485, EC Directives for CE marking on products, Clinical trial and Pro...

Tags for this Online Resume: Management, Medical, Operating Room, Policies and Procedures, Project Management, Rf, Software, Software Development, Surgical, Test

Quality Professional

Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...

Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis

Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry

PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...

Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device

Plant Manager - 20 Years of Experience - Near 22000

PROFILE Entrepreneurial manager with extensive international experience and an astute understanding of operations management and business processes in consumer products manufacturing industries. Adept at analyzing business operations and applying strategic tactics that minimize bottom line costs and maximize profitability, while also improving organization effectiveness and customer satisfaction. Demonstrated success direct...

Tags for this Online Resume: Layout, Logistics, SAN (Storage Area Network), Surgical, apparel, Construction, Distribution, Manufacturing, Accounting, BPCS

Medical Scientist - 8 Years of Experience - Near 44124

Summary devices. Worked in different stage of product life cycle from inspection to FDA and CE mark submission. As a P.h.D. candidate in Electrical Engineering have experience in research and analysis both within the U.S. and globally, in the fields of Mathematics, Statistics, Probability, and Image Processing. Able to adapt rapidly and be flexible to solve problems.

Tags for this Online Resume: Automation, Agile Methodologies, Agile methodology, Arabic Language, Biomedical Industry, C++ Programming Language, Cancer, Consulting, CT, Data Management, pharmaceutical, research, product development, Quality, FDA