Antoine Rudelle

Production Line installation of a class 2 sterile product for US market - Customer, schedule, budget and resources management - Cross-functional and international team management - Design review and validation of the product - Material sourcing: Validation of each components - Tooling manufacturing: Mold & specific production equipment's - Workflow set up and Sterilizer management - Process validation (IQ/OQ/PQ/PPQ, FAT/SAT) - DV products build - V&V master plan, sync external laboratory and follow-up Various additional D&D projects to manage in parallel

Development Projects following ISO13485 phases - Product requirements, Technicals Documentation, Quality and Regulatory documentation… - Industrialization (Labelling, packaging, work instruction…) Team’s mechanical Engineer : Responsible of injected parts - Mold manufacturer management - Part's design, 3D/2D realization - Optimization for injection Maintenance: Responsible of the production equipment’s maintenance on French Site Regulatory: - Upgrade Technical File for ISO 13485 - Build up technical file for 510(k) FDA - Write Risk Analysis Procedure & update it on several products - Usability studies on several products

Designer in the product development team Animal trial project: Design change request for the implant: - Request reception: Grasp the issue and challenge - Suggest concepts and dealing with short deadlines - Lead review and decisional meeting - Develop the design and drawings - Create processes for manufacture/assembly of parts New design project: Sub-system of the implant: - Input analysis: State of art, surgeon interviews, patents reviews - Writing requirements, design inputs - Research of concepts

Design of a sub-system of a left ventricular assist device - Input analysis: State of art, Surgeon interviews, patents reviews - Writing requirements, design inputs - Research of concepts - Prototyping: drawing, manufacturing: Follow up with supplier - Intermediate test and validation of the concepts, trial on pig heart

Design of an innovative hybrid transmission – in charge of the mechanical part of the project - State of art - Research of concepts - Calculation for dimensioning - Team work: Review and optimization with inputs from simulation (Energy consumption and control law) - Elaboration of a 3D model with Catia V5 and V6

Assisting the team in charge of the development of engine: - Calculation of fan consumption and use of beam theory - Tests follow-up : Diagnostics of failures - Calibration and template for utilisation of measurement material - Project management : using Gantt in order to follow progress of different projects, organize meetings

Master 2 en biomécanique, à l'école Polytechnique.

Classe préparatoire aux grandes écoles en PTSI - PT à Joliot Curie à Rennes.