Senior R&D Test Engineer / ingénieur principal en essais R&D at Boston Scientific Corporation Malaysia

Montreal, Quebec, Canada -

Full Time

Start Date

Immediate

Expiry Date

06 Apr, 26

Salary

158200.0

Posted On

06 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Electrical Engineering, Test Validation, Problem Solving, Verification and Validation, Collaboration, Analytical Skills, Documentation, Communication, Initiative, Risk Planning, Design for Manufacturability, Design for Test, LabVIEW, C/C++ Programming, SolidWorks, Statistical Analysis

Industry

Medical Equipment Manufacturing

Description

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 As a Senior R&D Test Engineer, you will contribute to the design, validation, and continuous improvement of test systems for Boston Scientific’s cutting-edge medical devices. In this role, you will be part of the growing Electrophysiology (EP) Capital Equipment team, responsible for developing and executing comprehensive verification and validation activities for complex electrical and electromechanical systems. Your responsibilities will include: Analyzing system and design requirements to develop comprehensive test plans, protocols, and reports that ensure designs meet all specifications and standards. Applying technical knowledge to design, develop, and validate test methods, processes, fixtures, and automation systems. Performing engineering, functional, and performance testing on electrical and electro-mechanical components, subsystems, and complete systems. Monitoring and analyzing test results, generating detailed technical reports, and providing recommendations to improve design and manufacturability. Providing Design for Manufacturability (DFM) and Design for Test (DFT) input during design and development reviews. Leading or supporting equipment and process validations (IQ/OQ/PQ) as part of the Quality System. Collaborating with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs to ensure alignment with design and process requirements. Providing technical guidance, mentorship, and occasional training to technicians or test personnel during validation or development activities. Demonstrating a strong commitment to patient safety and product quality by adhering to Boston Scientific’s Quality Policy and procedures. Other duties as required. Required qualifications: Bachelor’s degree in electrical engineering or a related field. 6+ years of experience in product or system development within a regulated industry. Solid understanding of engineering and problem-solving principles, as well as fundamentals of test validation and change management. Hands-on experience developing and executing verification and validation (V&V) tests for electrical or electro-mechanical systems. Ability to develop creative, data-driven solutions and collaborate effectively within cross-functional engineering teams. Strong analytical, organizational, and documentation skills. Excellent communication and collaboration abilities. Proven ability to take initiative, identify improvement opportunities, and drive them to completion. Resilience in handling challenges, with effective risk planning and problem-solving capabilities. Preferred qualifications: Experience in the medical device industry with familiarity in FDA 21 CFR 820 and ISO 13485 compliance. Experience in equipment and fixture design, test system development, and process validation. Proficiency with LabVIEW and/or C/C++ programming for test automation. Experience using SolidWorks for mechanical fixture design. Knowledge of automation systems or programmable logic controllers (PLCs). Experience with statistical analysis tools and data-driven decision-making (e.g., Minitab, JMP). Exposure to new product development processes, particularly within capital equipment or electromechanical systems. À propos du poste : En tant qu’ingénieur principal en essais R&D, vous contribuerez à la conception, à la validation et à l’amélioration continue des systèmes d’essais pour les dispositifs médicaux de pointe de Boston Scientific. Dans ce rôle, vous ferez partie de l’équipe en pleine croissance des équipements capitaux en électrophysiologie (EP), responsable du développement et de l’exécution d’activités complètes de vérification et de validation pour des systèmes électriques et électromécaniques complexes. Vos responsabilités comprendront : Analyser les exigences du système et de la conception afin de développer des plans d’essais, des protocoles et des rapports complets garantissant que les conceptions respectent toutes les spécifications et normes. Appliquer vos connaissances techniques pour concevoir, développer et valider des méthodes d’essai, des procédés, des gabarits et/ou des systèmes d’automatisation. Effectuer des essais d’ingénierie, fonctionnels et de performance sur des composants, sous-systèmes et systèmes électromécaniques complets. Surveiller et analyser les résultats d’essais, rédiger des rapports techniques détaillés et formuler des recommandations pour améliorer la conception et la fabricabilité. Fournir des commentaires en matière de conception pour la fabricabilité (DFM) et de conception pour les essais (DFT) lors des revues de conception et de développement. Diriger ou soutenir les activités de validation d’équipement et de procédé (IQ/OQ/PQ) dans le cadre du système de qualité. Collaborer avec des équipes interfonctionnelles, incluant R&D, Qualité, Fabrication et Affaires réglementaires, afin d’assurer l’alignement avec les exigences de conception et de procédé. Fournir des conseils techniques, du mentorat et, au besoin, de la formation aux techniciens ou au personnel d’essai pendant les activités de validation ou de développement. Démontrer un fort engagement envers la sécurité des patients et la qualité des produits en respectant la politique de qualité et les procédures de Boston Scientific. Autres tâches selon les besoins. Qualifications requises : Baccalauréat en génie électrique ou dans un domaine connexe. Plus de 6 ans d’expérience en développement de produits ou de systèmes dans une industrie réglementée. Excellente compréhension des principes d’ingénierie et de résolution de problèmes, ainsi que des notions de base de la validation des essais et de la gestion du changement. Expérience pratique dans le développement et l’exécution d’activités de vérification et validation (V&V) pour des systèmes électriques ou électromécaniques. Capacité à développer des solutions créatives et fondées sur les données, et à collaborer efficacement au sein d’équipes d’ingénierie multidisciplinaires. Solides compétences analytiques, organisationnelles et en documentation. Excellentes aptitudes en communication et en collaboration. Capacité démontrée à prendre des initiatives, à identifier des occasions d’amélioration et à les mener à terme. Résilience face aux défis, avec une planification efficace des risques et de solides compétences en résolution de problèmes. Qualifications préférées : Expérience dans l’industrie des dispositifs médicaux, avec une connaissance des exigences de conformité FDA 21 CFR 820 et ISO 13485. Expérience en conception d’équipements et de gabarits, en développement de systèmes d’essais et en validation de procédés. Maîtrise de LabVIEW et/ou de la programmation C/C++ pour l’automatisation des essais. Expérience avec SolidWorks pour la conception de gabarits mécaniques. Connaissance des systèmes d’automatisation ou des automates programmables industriels (API/PLC). Expérience avec les outils d’analyse statistique et la prise de décision fondée sur les données (p. ex. Minitab, JMP). Expérience dans les processus de développement de nouveaux produits, particulièrement dans les systèmes électromécaniques ou d’équipements capitaux. Requisition ID: 615994 Minimum Salary: $79700 Maximum Salary: $158200 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--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 Senior R&D Test Engineer / ingénieur principal en essais R&D 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 R&D Test Engineer / ingénieur principal en essais R&D 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!

Responsibilities

As a Senior R&D Test Engineer, you will design, validate, and improve test systems for medical devices, focusing on verification and validation activities for complex systems. You will collaborate with cross-functional teams to ensure alignment with design and process requirements.