Description
Entreprise :
Our customer is one of Switzerland's leading manufacturers of medical devices.
Description du poste :
Deliver Particulate studies re: USP 788, counting, sizing, identifying. Deliver Extractables & Leachables studies on new design Ceres Mod2DK with new tubing force and DK IT.
Procedure, test and report responsability and task management.
Deliver Particulate studies as per USP 788, counting, sizing, identifying.
Deliver Extractables & Leachables studies as per ISO 10993-18 on new design Ceres Mod2DK with new tubing force and DK IT.
Description du profil :
Master degree in Material/Polymer Science, Material/Polymer Engineering, Biomedical Engineering, Biology Engineering or equivalent professional experience.
Minimum 10+ year-experience in a similar field.
Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.