Project Manager

vor 2 Wochen

Genf, Genf, Schweiz CDG Conseil Vollzeit

CDG Conseil, cabinet de conseil en recrutement, évaluation et coaching spécialisé dans l'industrie de la santé, recrute pour son client une société qui conçoit, développe des solutions chirurgicales innovantes pour la colonne vertébrale.

Notre client recherche un Project Manager Mécatronique pour son nouveau programme de solutions facilitantes pour exécuter le geste par assistance.

Project Manager Mécatronique H/F – DM

Genève

Sous la supervision du Senior Project and Innovation Manager, vous participerez activement au développement de dispositifs médicaux dans un environnement technique multidisciplinaire intégrant la mécatronique, les systèmes électroniques, la motorisation, le câblage, les cartes de circuits imprimés, les logiciels embarqués, ainsi que la testabilité fonctionnelle et réglementaire en assurant une approche globale et intégrée.

Vous serez chargé d'élaborer, coordonner et documenter le plan de tests fonctionnels et réglementaires en rédigeant les protocoles, les rapports de test et les analyses de risques nécessaires pour garantir la fiabilité et la sécurité des dispositifs. Vous veillerez également à assurer la conformité des dispositifs aux exigences réglementaires applicables telles que l'EU MDR 2017/745, ISO 13485, ISO 14971, IEC 60601, IEC 62366 et le 21CFR Part 820 en effectuant des contrôles rigoureux et en respectant les standards de qualité en vigueur.

Principales Responsabilités :

Définition du projet

  • Collaborer avec le Product Manager pour établir les spécifications
  • Traduire les besoins en spécifications fonctionnelles et techniques

Conception et développement du produit

  • Coordonner les expertises internes et externalisées (électronique, logiciel, mécanique, tests)
  • Définir et documenter la conception du système (procédures, câblage, nomenclature)
  • Respecter le calendrier, les exigences, les coûts, et les normes de qualité
  • Gérer la fabrication des prototypes et dispositifs de test avec les fabricants

Vérification et validation du produit

  • Définir le plan de test fonctionnel et réglementaire
  • Développer des méthodes et outils de test
  • Exécuter ou superviser les tests (fonctionnels, fiabilité, sécurité)
  • Mener des investigations techniques pour les tests de fiabilité
  • Rédiger la documentation, y compris les rapports de test, selon les exigences

Industrialisation du produit

  • Accompagner l'industrialisation des nouveaux produits
  • Définir les points de contrôle pour assurer la conformité

Gestion du cycle de vie du produit

  • Contribuer au processus NPI (New Product Introduction)
  • Participer à l'amélioration continue des produits
    • Diplôme en mécatronique, avec compétences en robotique, électronique, alimentation électrique, automatisation et mécanique.
    • 5 ans d'expérience en développement de projets dans un environnement réglementé et minimum 3 ans dans le secteur médical, avec bonne connaissance de la norme IEC 60601.
    • Expérience en tests de systèmes électroniques et gestion de campagnes de tests pour dispositifs médicaux intégrant de l'électronique (atout : codage de programmes de test, conception de bancs d'essai ou expérience en laboratoire).
    • Compétence en lecture de schémas électroniques et utilisation d'instruments de laboratoire.
    • Connaissance de la CEM et des certifications CE et FDA.
    • Excellente communication orale et écrite, maîtrise professionnelle de l'anglais.
    • Inventif, rigoureux, méticuleux, doté de compétences analytiques et en résolution de problèmes, avec curiosité et capacité à travailler en équipe multidisciplinaire.
    • Adaptabilité et sens de l'organisation.
    • Connaissance des moteurs chirurgicaux, systèmes d'imagerie médicale, robotique et navigation, ainsi que de la norme IEC 62304, serait un plus.

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