Additional Locations:Canada:QC:Montreal Diversity : Innovation : Caring : Global Collaboration : Winning Spirit : High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high:performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing : whatever your ambitions. About the role The ideal Principal Design Quality Engineer will bring their leadership to new product development projects and sustaining projects for our innovative cardiovascular products. Furthermore, they will develop, establish, and maintain quality:engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Your responsibilities will include: : Develops understanding of design controls, risk management, and usability for medical devices : Provides quality and compliance input to project teams for project decisions and deliverables (e.g., design change analysis, design inputs, design outputs, test methods, design reviews, design verification and validation, usability testing, software validation, process validation, and labeling) : Provides quality and compliance input for post:market product sustaining activities, such as design changes, NCEPs, CAPAs, PIRs, field signal evaluations, and field actions : Applies technical skills including sound, systematic problem:solving methodologies in identifying, prioritizing, communicating, and resolving quality issues : Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements : Builds quality into all aspects of work by maintaining compliance with all quality requirements : Supports internal and external regulatory audits as required : Performs other duties as necessary or as required by the organization Required qualifications: : Bachelor's degree in mechanical, electrical, or biomedical engineering, or equivalent. : 7+ years of relevant work experience relating to quality assurance in a highly regulated industry (ideally medical devices) Preferred Qualifications : Focus on detailed work with emphasis on accuracy and completeness : Excellent organizational and planning skills; drives for results : Strong communication (oral and written) and presentation skills : High energy problem solver capable of driving items to closure : Ability to collaborate and work on a global team À propos du poste L'ingénieur principal en assurance de la qualité de la conception idéal exerce son leadership dans le cadre de projets de développement de nouveaux produits et de projets de soutien pour nos produits cardiovasculaires novateurs. En outre, il développe, établit et assure la mise en ouvre de méthodologies, de systèmes et de pratiques d'ingénierie appliqués à l'assurance de la qualité qui répondent aux exigences de BSC, des clients et des autorités de réglementation. Responsabilités : Comprendre les contrôles de conception, la gestion des risques et la facilité d'utilisation des dispositifs médicaux. : Fournir des informations sur la qualité et la conformité aux équipes responsables des projets en ce qui concerne les décisions à prendre et les produits livrables (c'est:à:dire l'analyse des changements relatifs à la conception, les données d'entrée de la conception, les données de sortie de la conception, les méthodes d'essai, les revues de la conception, la vérification et la validation de la conception, les essais de facilité d'utilisation, la validation des logiciels, la validation des processus et l'étiquetage). : Fournir des informations sur la qualité et la conformité pour les a