R&d Project Manager

vor 11 Stunden


Fribourg, Schweiz Axepta SA Vollzeit

**Poste**: Chef de projets R&D (classe III)

**Lieu **:Genève

**Profil**: 3 ans d'experience minimum dans les dispositifs medicaux de classe III sur un poste similaire.

Pour notre client, acteur incontournable des Medtech & de renomée mondiale, nous recherchons un **Chef de projets R&D.**

**Responsabilités**:

- Contribuer à la conception et au développement de nouveaux produits.
- Coordonner plusieurs projets simultanément.
- Interagir avec les différents départements de l'entreprise, intervenir dans les différentes étapes des projets, de la conception au lancement du produit.
- Contribuer à la maintenance des lignes de produits existantes.
- Assurer la conformité avec les exigences réglementaires applicables ISO 13485, 21CFR Part 820 et MDR 2017/745 (EU).
- Vous serez responsable du prototypage et de la fabrication de dispositifs d'essai en collaboration avec des fabricants internes et externes.
- Établir un plan d'essai, exécuter ou surveiller les essais
- Contribuer au transfert de la conception des nouveaux produits
- Rédiger toute la documentation associée, effectuer l'analyse des risques et le plan directeur de vérification/validation de la conception conformément aux exigences réglementaires et de qualité.
- Gérer le fichier historique de la conception (DHF) pour le projet.

**Votre profil**:

- Diplôme d'ingénieur en mécanique ou équivalent avec un minimum de** 3 ans** d'expérience en tant que **chef de projet en R&D **dans l'industrie des dispositifs médicaux.
- Connaissance des normes et réglementations associées aux dispositifs médicaux telles que **ISO 13 485, 21CFR Part 820 et MDR 2017/745 (EU).**:

- Une connaissance/expérience de SolidWorks est un plus.
- La maîtrise du **français et de l'anglais est requise



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