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 les équipes interfonctionnelles afin de favoriser le succès de l’organisation en protégeant la sécurité des patients et des utilisateurs et en répondant aux besoins de l’entreprise.

Mode de travail :

Chez Boston Scientific, nous valorisons la collaboration et la synergie. Ce poste hybride est basé à Montréal (Canada) et exige une présence sur site d’au moins trois (3) jours par semaine.

Parrainage de visa :

À l’heure actuelle, Boston Scientific n’offrira pas de parrainage ni ne prendra en charge le transfert du parrainage d’un visa de travail pour ce poste.

Vos responsabilités comprendront :

• Appliquer des méthodologies rigoureuses et systématiques de résolution de problèmes pour identifier, prioriser, communiquer et résoudre les problèmes de qualité.
• Élaborer et exécuter des plans de contrôle de la conception et de gestion des risques pour des projets complexes.
• Mettre à jour et maintenir les dossiers de gestion des risques, notamment les analyses des dangers (Hazard Analysis), les analyses des tâches (Task Analysis) et les AMDEC de conception (Design FMEA).
• Fournir une expertise en qualité de conception et en conformité aux équipes de projet pour les décisions et livrables de projet (p. ex. analyses des changements de conception, intrants et extrants de conception, méthodes de test, revues de conception, vérification et validation de la conception, essais d’utilisabilité, validation logicielle, validation des procédés et étiquetage).
• Assurer l’exécution et l’investigation des CAPA, des NCÉP (NCEP), des enquêtes sur les défaillances, etc.
• Participer à la prise de décision au sein de l’équipe et démontrer de solides compétences en communication, en collaboration et en résolution de problèmes.

Qualifications requises :

• Baccalauréat en génie mécanique, électrique, logiciel, biomédical ou dans une discipline technique connexe.
• Minimum de 2 ans d’expérience en assurance qualité, qualité de conception ou dans un domaine connexe de l’industrie des dispositifs médicaux ou d’une industrie réglementée.
• Connaissance des exigences de base des systèmes qualité et des bonnes pratiques de documentation.
• Excellentes aptitudes à résoudre les problèmes et à mener les dossiers jusqu’à leur clôture.
• Capacité à travailler efficacement dans un environnement collaboratif et en autonomie.
• Excellentes compétences en communication orale et écrite.

Qualifications souhaitées:

• Expérience démontrée dans un environnement réglementé de dispositifs médicaux, idéalement dans une fonction qualité.
• Expérience de travail avec des équipes interfonctionnelles et de gestion de projets jusqu’à leur réalisation.
• Expérience préalable dans les domaines suivants : contrôles de conception, CAPA et gestion des risques.
• Expérience avec les équipements d’investissement (capital equipment).

Requisition ID: 629691

Minimum Salary: $59,900 

Maximum Salary: $108,900 

The anticipated compensation and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Compensation for hourly, non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for salaried, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).

Our organization is across Canada and has commercial representation in 140 countries.

This job involves regular collaboration with colleagues, clients, and stakeholders across Canada, the U.S., and/or internationally, making proficiency in English essential for effective communication and alignment. English is necessary for engaging with a range of documentation and maintaining effective communication if interacting with external clients or vendors.

As detailed in the job description, this job involves communicating, both verbally and in writing, with other Boston Scientific teams located across Canada, the United States and/or with our international clients and partners. International customers and partners represent an important part of our activities. Based on an evaluation, we have determined that the duties of Design Quality II/Qualité de conception II position require knowledge of English in addition to French (oral and written). We also determined that the English language skills already required of other employees do not permit the performance of English language skills tasks related to Design Quality II/Qualité de conception II position.

However, in Québec, Boston Scientific limits as much as possible the number of positions for which it requires the knowledge of another language than French. Boston Scientific solely requires proficiency in English where it is necessary for the performance of an employee’s duties.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!