Additional Locations: Canada-QC-Montreal Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, well give you the opportunity to harness all thats 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, well help you in advancing your skills and career.

Here, youll be supported in progressing whatever your ambitions.

French translation to follow About the role: We have a high-impact chance for a Senior Design Quality professional 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.

The Senior Design Quality role 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 hybridrole is based at the Montreal, Canadalocation 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: Serve as the technical authority within Quality for system integration,design decisions,risk management,andsoftwaredevelopment &validation.;

Independently lead design control activities for the Capital Equipment, including

Design & Developmentplanning, risk management, design verification, and validation efforts, with a strong focus onrobustness ofsystem design and documentation.

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

Own andmaintaincomprehensive risk management files (Hazard Analysis, FMEAs), ensuring robust coverage of both hardware,software, and systemrisks, applying advanced risk mitigation strategiesto influence robust design decisions Lead root cause investigations and resolutionof 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.

Proactivelyidentifygaps and opportunities for continuous improvement inproduct developmentprocesses, 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. 7+ years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in the medical device industry.

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

Proven ability to independently lead complexproduct developmentprojects, including softwareand systemquality assurance activities, frominceptionthrough completion.

Experience developing andmaintainingrisk documentation such as FMEAs and Hazard Analyses witha hardware, softwareand systemfocus.

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/systemsengineeringactivities.

Experience with Capital Equipment Knowledge of software quality standards (IEC 62304)



and software/system developmentprinciples.

Prior experience working on or supportingcardiac mapping systemsor similar complex medical device platforms.

Strong project management skills and familiarity with agile development methodologies. propos du poste: Nous offrons une opportunit fort impact pour un(e) professionnel(le) senior en qualit de conception afin de diriger les activits dassurance qualit de conception pour un dispositif mdical critique dans le domaine de llectrophysiologie.

Ce rle ncessite une personne autonome capable de grer de faon indpendante des dfis techniques complexes et de dvelopper des solutions couvrant les domaines matriel, logiciel et systme. ce titre, vous influencerez les initiatives stratgiques en qualit, encadrerez des ingnieurs juniors et agirez comme ressource cl auprs dquipes interfonctionnelles afin dassurer la scurit des produits, la conformit rglementaire et la robustesse de conception.

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

Ce poste hybride est bas Montral, Canada, et requiert une prsence sur site dau moins trois (3) jours par semaine.

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

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

Diriger de faon autonome les activits de contrle de conception pour les quipements, incluant la planification de la conception et du dveloppement, la gestion des risques, la vrification et la validation de conception, avec un fort accent sur la robustesse de la conception et de la documentation systme.

Collaborer troitement avec les quipes R&D;, rglementaires, de fabrication et cliniques afin de fournir des conseils dexpert sur les aspects de conception et de conformit tout au long du cycle de vie du produit.

Assurer la gestion et le maintien des dossiers complets de gestion des risques (analyses des dangers, AMDE/FMEA), en couvrant le matriel, les logiciels et les systmes, et en appliquant des stratgies avances dattnuation des risques pour orienter les dcisions de conception.

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

Offrir du mentorat et du soutien aux ingnieurs juniors en matire de meilleures pratiques dassurance qualit de conception, dexigences rglementaires et de processus qualit.

Identifier de manire proactive les lacunes et les opportunits damlioration continue des processus, outils et documents de dveloppement de produits.

Agir comme principal point de contact pour lassurance qualit de conception lors des audits internes, externes et inspections rglementaires.

Grer efficacement plusieurs priorits et projets de faon autonome, faire preuve dun solide jugement en contexte dambigut et influencer les quipes projet vers des dcisions et comportements axs sur la qualit.

Qualifications requises: Baccalaurat en gnie mcanique, lectrique, logiciel, biomdical ou dans une discipline technique connexe. 7+ annes dexprience en assurance qualit, qualit de conception, qualit logicielle ou rles connexes dans 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 prouve diriger de faon autonome des projets complexes de dveloppement de produits, incluant des activits qualit pour les logiciels et les systmes, de la conception la ralisation.

Exprience dans llaboration et le maintien de la documentation des risques (AMDE/FMEA, analyses des dangers) avec une porte couvrant le matriel, les logiciels et les systmes.





Solides comptences en rsolution de problmes, incluant la direction danalyses des causes fondamentales et denqutes CAPA.

Excellentes habilets de communication, avec la capacit dinfluencer des parties prenantes tous les niveaux et de diriger des initiatives interfonctionnelles.

Capacit voluer dans un environnement dynamique et naviguer dans lambigut avec un jugement clair.

Qualifications souhaites: Exprience en mentorat ou en encadrement dingnieurs juniors dans des activits dassurance qualit de conception ou dingnierie logicielle/systmes.

Exprience avec des quipements capitaux.

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

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

Solides comptences en gestion de projet et familiarit avec les mthodologies de dveloppement agiles.

Requisition ID: 629670 Minimum Salary: $83,300 Maximum Salary: $132,300 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 Senior Design Quality / Qualit de conception senior 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 Senior Design Quality / Qualit de conception senior 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!

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