About the role: We have a high-impact prospect for a Design Quality III to lead design assurance efforts for a critical medical device in the Electrophysiology space.

This role requires a self-driven professional capable of independently managing complex technical challenges and driving to solutions across hardware, software, and system domains.

They will influence strategic quality initiatives, mentor junior engineers, and serve as a key resource in cross-functional teams to ensure product safety, regulatory compliance, and design robustness.

Work Mode: At Boston Scientific, we value collaboration and synergy.

This role follows a hybrid work model, requiring employees to be in our Montreal, QC office at least three 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: Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation.

Independently lead design control activities for the Capital Equipment, including Design & Development planning, risk management, design verification, and validation efforts, with a solid focus on robustness of system design and documentation.

Collaborate closely with R&D;, regulatory, manufacturing, and clinical teams to provide expert guidance on design and compliance matters throughout the product lifecycle.

Own and maintain comprehensive risk management files (Hazard Analysis, FMEAs), ensuring robust coverage of both hardware, software, and system risks, applying advanced risk mitigation strategies to influence robust design decisions Lead root cause investigations and resolution of test failures, CAPAs, NCEPs, and complaints, driving corrective actions and preventive measures with minimal oversight.

Provide mentorship and guidance to junior engineers on design assurance best practices, regulatory requirements, and quality processes.

Proactively identify gaps and opportunities for continuous improvement in product development processes, tools, and documentation.

Act as a primary point of contact for design assurance during internal and external audits and regulatory inspections.

Effectively manage multiple priorities and projects independently, demonstrating strong decision-making skills in ambiguous situations, and ability to influence project team towards quality-centric decisions and behaviors Required Qualifications Bachelors degree in Mechanical, Electrical, Software Engineering, Biomedical Engineering, or related technical discipline. 6+ years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in the medical device industry.

Demonstrated expertise in Design Controls, Risk Management (ISO 14971), Quality System Regulations (21 CFR 820), and Quality management systems (ISO 13485).

Proven ability to independently lead complex product development projects, including software and system quality assurance activities, from inception through completion.

Experience developing and maintaining risk documentation such as FMEAs and Hazard Analyses with a hardware, software and system focus.

Strong problem-solving skills with experience leading root cause analysis and CAPA investigations.

Excellent communication skills, capable of influencing stakeholders at all levels and leading cross-functional initiatives.

Ability to thrive in a fast-paced environment and navigate ambiguity with sound judgment.

Preferred Qualifications Experience mentoring or leading junior engineers in design assurance or software/systems engineering activities.

Experience with Capital Equipment Knowledge of software quality standards (IEC 62304) and software/system development principles.

Prior experience working on or supporting cardiac mapping systems or similar complex medical device platforms.

Strong project management skills and familiarity with agile development methodologies. propos du poste: Nous avons une occasion fort impact pour un(e) Spcialiste qualit de conception III (Design Quality III) qui dirigera les activits dassurance qualit de la conception pour un dispositif mdical critique dans le domaine de llectrophysiologie.

Ce poste exige un(e)



professionnel(le) autonome capable de grer de faon indpendante des dfis techniques complexes et de piloter des solutions touchant le matriel, les logiciels et les systmes.

Cette personne influencera les initiatives stratgiques en matire de qualit, encadrera des ingnieurs juniors et agira comme ressource cl au sein dquipes multidisciplinaires afin dassurer la scurit des produits, la conformit rglementaire et la robustesse de la conception.

Mode de travail: Chez Boston Scientific, nous valorisons la collaboration et la synergie.

Ce poste suit un modle de travail hybride exigeant une prsence au bureau de Montral (Qubec) au moins trois jours par semaine.

Parrainage de visa: Boston Scientific noffrira pas de parrainage ni ne prendra en charge le parrainage dun visa de travail pour ce poste lheure actuelle.

Vos responsabilits comprendront: Agir titre dautorit technique au sein de la fonction Qualit pour lintgration des systmes, les dcisions de conception, la gestion des risques ainsi que le dveloppement et la validation des logiciels.

Diriger de manire autonome les activits de contrle de la conception pour les quipements dimmobilisation (Capital Equipment), notamment la planification de la conception et du dveloppement, la gestion des risques, la vrification et la validation de la conception, avec un fort accent sur la robustesse de la conception des systmes et de la documentation.

Collaborer troitement avec les quipes de R-D, des affaires rglementaires, de la fabrication et des affaires cliniques afin de fournir une expertise sur les questions de conception et de conformit tout au long du cycle de vie du produit. tre responsable de la cration et du maintien des dossiers complets de gestion des risques (analyse des dangers, AMDE/FMEA), en assurant une couverture robuste des risques lis au matriel, aux logiciels et aux systmes, tout en appliquant des stratgies avances dattnuation des risques afin dinfluencer des dcisions de conception robustes.

Diriger les enqutes sur les causes fondamentales et la rsolution des checs de tests, des CAPA, des NCEP et des plaintes, en mettant en uvre des actions correctives et prventives avec un minimum de supervision.

Fournir du mentorat et des conseils aux ingnieurs juniors concernant les meilleures pratiques en assurance de la conception, les exigences rglementaires et les processus qualit.

Identifier de manire proactive les lacunes et les occasions damlioration continue des processus de dveloppement de produits, des outils et de la documentation.

Agir comme principal point de contact pour lassurance de la conception lors des audits internes et externes ainsi que des inspections rglementaires.

Grer efficacement plusieurs priorits et projets de faon autonome, dmontrer une solide capacit de prise de dcision dans des situations ambigus et influencer les quipes de projet vers des dcisions et des comportements axs sur la qualit.

Qualifications requises Baccalaurat en gnie mcanique, gnie lectrique, gnie logiciel, gnie biomdical ou dans une discipline technique connexe.

Plus de 6 ans dexprience en assurance qualit, assurance de la conception, qualit logicielle ou dans des fonctions connexes au sein de lindustrie des dispositifs mdicaux.

Expertise dmontre en contrles de conception, gestion des risques (ISO 14971), rglementation des systmes qualit (21 CFR 820) et systmes de gestion de la qualit (ISO 13485).

Capacit dmontre diriger de faon autonome des projets complexes de dveloppement de produits, y compris les activits dassurance qualit des logiciels et des systmes, de leur conception leur ralisation.

Exprience dans llaboration et le maintien de la documentation de gestion des risques, notamment les AMDE (FMEA) et les analyses des dangers, avec une perspective intgrant le matriel, les logiciels et les systmes.

Excellentes aptitudes la rsolution de problmes,



avec exprience dans la conduite danalyses des causes fondamentales et denqutes CAPA.

Excellentes comptences en communication, avec la capacit dinfluencer des intervenants tous les niveaux et de diriger des initiatives multidisciplinaires.

Capacit voluer dans un environnement dynamique et grer lambigut avec discernement.

Qualifications privilgies Exprience en mentorat ou en leadership dingnieurs juniors dans le cadre dactivits dassurance de la conception ou dingnierie logicielle/systmes.

Exprience avec les quipements dimmobilisation (Capital Equipment).

Connaissance des normes de qualit logicielle (IEC 62304) et des principes de dveloppement logiciel et systme.

Exprience pralable sur des systmes de cartographie cardiaque ou des plateformes de dispositifs mdicaux complexes similaires.

Solides comptences en gestion de projet et connaissance des mthodologies de dveloppement Agile.

Requisition ID: 629845 Minimum Salary: $69,400 Maximum Salary: $118,400 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 III / Qualit de conception III 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 III / Qualit de conception III position.

However, in Qubec, 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 employees 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) isnt just business, its personal.

And if youre 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!

📌 Design Quality III / Qualité de conception III (Montreal)
🏢 Boston Scientific
📍 Montreal