Design Quality II​/Qualité de conception II

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.

French translation to follow

About the role:

We have an exciting opportunity for a Design Quality II supporting capital equipment within the BSC Electrophysiology division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and sustaining engineering experience. In a hybrid work mode, the Design Quality Engineer II will support a team of engineers to apply the directives of design controls to projects such as design changes, regulatory and standards compliance, corrective and preventive actions, and sustaining projects.

They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Work mode:

At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Montreal, QC, Canada location and requires being on-site at least three (3) days per week.

Visa sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include:

• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Develops and executes plans for design control and risk management of complex projects
• Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
• Provide design quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
• Responsible for the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Participate in team decision-making and demonstrate strong communication and collaborative problem-solving skills.

Required Qualifications

• Bachelor’s degree in Mechanical, Electrical, Software Engineering, Biomedical Engineering, or related technical discipline.
• 2+ years experience in design assurance, quality, or related medical device or regulated industry experience.
• Knowledge of basic Quality System Requirements and Good Documentation Practices
• High energy problem solver capable of driving items to closure
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)

Preferred Qualifications

• Proven experience in a regulated medical device environment, preferably in a quality function
• Experience working with cross-functional teams and driving projects to completion.
• Prior interactions with the following disciplines: design controls, CAPA, risk management
• Experience with Capital Equipment

À propos du poste :

Nous avons une excellente opportunité pour un(e) Ingénieur(e) Qualité de Conception II soutenant les équipements d’investissement (capital equipment) au sein de la division Électrophysiologie de Boston Scientific. Ce poste joue un rôle important dans le soutien aux activités d’assurance qualité de produits complexes et d’équipements de capital tout au long du cycle de vie du produit. Dans ce rôle hybride, l’Ingénieur(e) Qualité de Conception II apportera une expertise aux équipes de projet concernant les modifications de conception, les exigences réglementaires et les normes de conformité, les actions correctives et préventives, ainsi que les projets de maintien des produits.

La personne titulaire du poste sera responsable de maintenir de solides partenariats de collaboration avec…