Boston Scientific Design Quality Engineer / Ingénieur en qualité de la conception 

Canada, Quebec, Montreal 

218073328

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 Design Assurance Quality Engineer (DQA) will work alongside the R&D team to iterate on existing commercial products and perform new product development activities. The DQA Engineer will provide input into the software development processes and ensure product development lifecycle compliance. You will contribute to process improvements (customer experience, manufacturing and servicing), conduct risk assessments, and support regulatory submissions, ensuring compliance with industry standards. This role involves close collaboration with cross-functional teams to evaluate and validate systems.

Your responsibilities will include:

• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Provide 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 Verification and Validation, Usability Testing, Software Validation, Process Validation and Labeling).
• Provide support in developing Software Development Plans, Unit & Integration Test Plans.
• Review and provide input to Software Detailed Design and Architectures.
• Provide quality and compliance input for post market product sustaining activities, such as design changes, non-conforming events, Corrective and Preventive Actions (CAPA), Field Signals Evaluations and Field Actions.
• Contributes to product risk assessment activities and perform Design FMEA’s activities
• Support the product’s cybersecurity file as per external standards and internal processes
• Support security risk assessments for medical devices products in development and commercialized.
• Own post-market cybersecurity deliverables for products commercialized (i.e. Vulnerability disclosures and monitoring).
• Assists Regulatory with product submissions.
• Support Non-Device Software tool validation.
• Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.
• Other duties as necessary or required by the organization.

Required qualifications:

• Bachelor or Master of Electrical, Biomedical, Computer Science, or equivalent.
• 1+ years of experience with product development activities in a regulated industry.
• Experience in Software Engineering.
• Strong problem-solving skills in a team environment.
• Excellent organizational, communication and collaboration skills.
• Familiar with JIRA
• Familiar with QMS Systems (Windchill, Master Control etc.)

À propos du poste

L’ingénieur(e) en assurance qualité de conception (DQA) travaillera aux côtés de l’équipe R&D pour itérer sur des produits commerciaux existants et réaliser des activités de développement de nouveaux produits. L’ingénieur(e) DQA apportera son expertise dans les processus de développement logiciel et s’assurera de la conformité au cycle de vie du développement de produit. Vous contribuerez à l’amélioration des processus (expérience client, fabrication et service après-vente), réaliserez des évaluations des risques et appuierez les soumissions réglementaires, en garantissant la conformité aux normes de l’industrie. Ce rôle implique une collaboration étroite avec des équipes interfonctionnelles pour évaluer et valider les systèmes.

Vos responsabilités comprendront :

• Développer une compréhension des contrôles de conception, de la gestion des risques et de l’utilisabilité des dispositifs médicaux.
• Fournir des conseils en matière de qualité et de conformité aux équipes de projet pour orienter les décisions et les livrables (p. ex. analyse des changements de conception, exigences de conception, résultats de conception, méthodes de test, revues de conception, vérification et validation de conception, tests d’utilisabilité, validation logicielle, validation des procédés et étiquetage).
• Soutenir l’élaboration de plans de développement logiciel ainsi que de plans de tests unitaires et d’intégration.
• Examiner et fournir des commentaires sur les conceptions détaillées et les architectures logicielles.
• Apporter des conseils qualité et conformité pour les activités de maintien des produits après leur mise sur le marché, telles que les modifications de conception, les événements de non-conformité, les actions correctives et préventives (CAPA), l’évaluation des signaux terrain et les actions terrain.
• Contribuer aux activités d’évaluation des risques produit et réaliser des AMDE de conception (analyses des modes de défaillance et de leurs effets).
• Appuyer le dossier de cybersécurité des produits selon les normes externes et les processus internes.
• Soutenir les évaluations des risques de sécurité pour les dispositifs médicaux en développement et commercialisés.
• Assumer la responsabilité des livrables de cybersécurité post-marché pour les produits commercialisés (p. ex. divulgation et suivi des vulnérabilités).
• Assister l’équipe réglementaire dans les soumissions de produits.
• Soutenir la validation des outils logiciels non liés aux dispositifs.
• Améliorer continuellement les processus et méthodes de travail (en appliquant des principes agiles/lean pour éliminer le gaspillage) afin de contribuer à la résolution de problèmes complexes et interdisciplinaires en collaborant avec ses pairs et des groupes interfonctionnels.
• Exécuter toute autre tâche jugée nécessaire ou exigée par l’organisation.

Qualifications requises:

• Baccalauréat ou maîtrise en génie électrique, biomédical, informatique ou équivalent.
• Minimum d’un (1) an d’expérience en activités de développement de produits dans une industrie réglementée.
• Expérience en ingénierie logicielle.
• Solides compétences en résolution de problèmes dans un environnement de travail en équipe.
• Excellentes aptitudes en organisation, communication et collaboration.
• Familiarité avec JIRA.
• Familiarité avec les systèmes de gestion de la qualité (p. ex. Windchill, MasterControl, etc.).

Requisition ID: 613360

Minimum Salary: $49700

Maximum Salary: $98900

The anticipated compensation listed above 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. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

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 Engineer I / Ingénieur en qualité de la conception 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 Engineer I / Ingénieur en qualité de la conception 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!