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Software Quality Engineer

vor 2 Monaten


Genève, Schweiz Swissels Engineering & Life Science Services Vollzeit

TACHES & RESPONSABILITES

-Mettre en place tous les outils et procédures nécessaires pour développer le firmware et le logiciel

en conformité avec les normes IEC 62304 et ISO 13485.

-Développer les procédures d'exploitation standard du logiciel, les méthodologies de test du logiciel

et les protocoles et rapports de vérification et de validation du logiciel.

-Rédiger toutes les spécifications du logiciel.

-Diriger les activités de gestion des risques (identification des dangers, évaluation des risques et

contrôle des risques) pour tous les développements logiciels et participer aux activités de gestion des

risques du projet global avec l'équipe.

-Conseiller et soutenir les ingénieurs en matière de conformité réglementaire pour les logiciels et le

règlement général sur la protection des données.

-Diriger la validation des logiciels utilisés pour la surveillance et la mesure des exigences et utilisés

dans le système de gestion de la qualité (AAMI TIR 36).

-Collaborer avec les membres de l'équipe pour déterminer les meilleures pratiques et les exigences

pour les logiciels.

-Élaborer les spécifications du produit en prêtant attention à l'intégration et à la faisabilité du

système.

-Planifier, suivre et programmer les livrables logiciels

-Coordonner et superviser les normes techniques en collaboration avec l'équipe QA/RA, y compris les

normes de codage des logiciels, les outils et les plateformes.

-Assurer des activités efficaces de contrôle des changements pendant le cycle de vie du produit.

-Créer la documentation requise (fichier d'historique de conception) pour chaque version de logiciel.

-Créer et soutenir les protocoles de test pour la vérification et la validation du matériel et des logiciels

embarqués.

-Travailler en étroite collaboration avec d'autres membres de l'équipe pour mener à bien l'étude

clinique des prototypes et obtenir les approbations réglementaires.

Gérer de manière indépendante les fournisseurs tiers, y compris les fournisseurs de composants

Education, formation et expérience

Maîtrise en génie logiciel ou équivalent, plus 5 ans d'expérience professionnelle.

Excellente connaissance de la norme CEI 62304. 

Doit avoir déjà mis en œuvre le processus et les outils nécessaires pour développer des micrologiciels et des logiciels conformément à cette norme.

Parfaite maîtrise du français, excellente maîtrise de l'anglais.

Expérience de la validation des logiciels par la FDA, des directives en matière de cybersécurité, de

protection des données et d'intelligence artificielle.

Connaissance approfondie de l'ingénierie logicielle, à la fois des processus et des outils (y compris

l'intégration continue et les tests).

Expérience de la gestion des risques logiciels pour les dispositifs médicaux de classe IIa (ou

supérieure).

Solide expérience dans le développement de produits structurés (ingénierie axée sur les besoins,

modélisation de l'architecture, conception détaillée, AMDE des logiciels, vérification formelle,

processus de lancement, etc.)

Expérience du développement dans le cadre d'un SMQ certifié ISO 13485.

Capacité avérée à travailler dans un environnement de démarrage rapide au sein d'une petite

équipe.