Benjamin Straub

Creation, documentation and training of the team for the Quality Management System. Supervision of the Device Development Documentation (Technical File). Training of management and young people of a start-up regarding Medical Device requirements and subtilities.

Ensure GMP documentation in accordance with internal procedures and Health Authorities / international standards requirements and ensure sound technical content for internal Knowledge Management. Participation of creation, review and signature of all Design History File documents, like Risk Management, Project Planning, Design Inputs, Design Outputs, Design Verification, Design Validation, Process Development, Test Method Validation, Change Management, Discrepancies Management, etc.

Management of Quality aspects of CMOs like Quality Agreements, Deviations, Changes, Supply Specifications, Contracts, etc. Other task was the management of QA aspects for the Device Development project documentation, like Risk Management, Design Input Design Outputs, Design Verification, Design Validation, Process Development, Changes, Deviations, etc.

Within the CAD/CAM project, lead of project and technical development of helping parts in order to allow a scanner+software system to find the position of a dental implant in a cast model or in the oral cavity of a patient (scanbodies for Etkon System). Other activities : project lead for Plan Abutments and Life Cycle Management for BU Prosthetics.

Senior Product Development Engineer for medical Implants in traumatology (2000-2004) and in CMF-Neuro/Thorax (2005-2008), Plates, Screws and general Instrumentation for bone fixation. Together with the Product Manager, development of implants and their associated instruments. Main project in Traumatology: LCP, system of implants, where the screws are locked in the plate with angular stability.

Chef de projet adjoint, en charge de la conception / réalisation / suivi de 21 machine d'assemblages automatiques pour moteur de voiture sur ligne d'assemblage

Recréer un lien entre le Bureau d'études et la Production

Secrétaire du Colonel au Budget de l'Armée Française au sein du Corps Européen de Strasbourg

Génie Mécanique Ingénierie de Production

conception mécanique, dessin industriel