Project Manager Medical Device

Biomedical Engineer

seeking a challenging position in the field of medical devices

located in the Bay Area, California

Work Experience

Medtronic France – Boulogne Billancourt, France 2009 – Now

National Clinical Specialist in the Cardiac Rhythm Disease Management department

• Technical support during implants / follow-up of implantable cardiac defibrillators and pacemakers

• Hotline duty: assisted physicians, patients, sales reps, clinical specialists with technical issues

• Vigilance: managed incident cases at a national level

• Education: delivered presentation to physicians, nurses, new employees, new clinical specialists

• Developed new tools and documents for clinical specialists and sales reps

Keywords: Technical support, Defibrillator, Pacemaker, Hotline, Planning management, Education, Mobility

Air Liquide Medical Systems – Anthony, France 2009

Intern as Quality Engineer – 5 months

• Prepared the introduction of a new medical device in Canada

• Determined the product safety and efficiency requirements

• Answered the Canada requirement about medical devices (vigilance, customer claim, traceability, labelling)

• Ensured to the Canadian requirement between the manufacturer and the distributor

• Recorded the medical device with the Canadian authorities

• Completed the existing procedures of the company

• Coordinated the required product tests for Canada with the project manager

Keywords: Health Canada, Canadian regulation, Medical device, CE Mark

Omnicare Clinical Research – Gentilly, France 2008

Summer job as clinical assistant – 3 months

• Safety unit: Phone contact with site investigators (English and French speakers) for the management of the serious adverse events occurring in clinical studies

• Accounting and human resources unit: Managed invoices and employees documents

• Clinical study unit: Managed the clinical studies archives

Keywords: Drug Safety, Clinical Study, Human Resources

Medtronic France – Boulogne Billancourt, France 2007 – 2008

Intern as Regulatory Engineer in the Regulatory affairs department – 6 months

• Managed incident cases on medical devices according to the device vigilance system

• Managed the field safety corrective action

• Regulatory management of the clinical studies

Keywords: Regulatory affairs, vigilance, clinical study, medical device, AFSSAPS

Hospital Saint Louis – Paris, France 2007

Summer job as biomedical technician in the biomedical department – 1 month

• Update of the hospital medical equipment database

Clariant – Trosly-Breuil, France 2006

Intern as Chemistry Technician in the Textile finishing research and application laboratory – 10 weeks

• Study of a new process for the cross-linkage of the cellulose

Educational Background

Cranfield University – Cranfield, England 2008 – 2009

• Master of Science in Medical Diagnostics

Skills: Principles of Medical Diagnosis Screening and Monitoring, Advanced Diagnostic Technologies, Bioinformatics, Biomedicine as a Business Venture, Translational Medicine, Principles of Design and Production in the Diagnostics Industry, Economics Ethics and Legislation Affecting Medical Diagnostics.

• Followed courses about US Regulation from the « Medical Technology Regulatory Affairs » MS

Skills: Introduction to US Food, Drugs & Cosmetics Act, Structure and mission of FDA, Key differences to EU model, Pre-market notification/Establishment registration, Quality System Regulation and QSIT, Device listing/Labelling, FDA enforcement powers.

University of Technology of Compiègne – Compiègne, France 2006 – 2009

• Master’s Degree majoring Biology with focus on Biomaterials and biomechanics

Skills: Physical and analytical chemistry, Organic chemistry, Inorganic chemistry, Chemical Engineering, Mathematics, Microcomputers.

University of Technology of Orsay – Orsay, France 2005 – 2006

• University Technology Diploma majoring Chemistry

Skills: Biological macromolecules, Cell Biology, Manufacturing management, materials science and engineering, Polymers, Artificial organs and Biorheology, Biomechanics system modelling, hospital equipment technologies

Medical University Paris V – Paris, France 2003 – 2005

• First year of Medical School

Skills: Biology, Chemistry, Physics, Biochemistry, Biophysics, Histology, Embryology, Physiology

Additional experiences

Coordinator, “Festupic” Association & “Comet” Association, Compiègne, France 2007

• Organization of a week of art events (plays, street animations, concerts…), companies seeking, companies management

• Organization of student parties during the semester

Keywords: Team management, social skills, incident management

Computer Science Skills

Office Automation Microsoft Office (Word, Excel, PowerPoint)

Database Access

Languages C, Visual Basic

Languages

French Mother tongue

English Fluent – eight months in English University

German Notions

Personal Interests and Activities

Music Clarinet, 9 years of practice and Piano, 3 years

Trips USA, Finland, Lapland, Sweden, United Kingdom, Spain, Lebanon, Germany, Switzerland

Hobbies International and French music, cinema, sport, reading...

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