Senior R&D Test Engineer ingénieur principal en essais R&D

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.

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 Scientifics cutting-edge medical 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 Scientifics Quality Policy and procedures.
• Other duties as required.

Required qualifications:

• Bachelors 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 quingénieur principal en essais R&D vous contribuerez à la conception à la validation et à lamélioration continue des systèmes dessais pour les dispositifs médicaux de pointe de Boston Scientific. Dans ce rôle vous ferez partie de léquipe en pleine croissance des équipements capitaux en électrophysiologie (EP) responsable du développement et de lexécution dactivités 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 dessais 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 dessai des procédés des gabarits et/ou des systèmes dautomatisation.
• Effectuer des essais dingénierie fonctionnels et de performance sur des composants sous-systèmes et systèmes électromécaniques complets.
• Surveiller et analyser les résultats dessais 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 déquipement 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 dassurer lalignement 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 dessai 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 dexpérience en développement de produits ou de systèmes dans une industrie réglementée.
• Excellente compréhension des principes dingénierie 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 lexécution dactivités 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 déquipes dingénierie 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 damélioration 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 lindustrie des dispositifs médicaux avec une connaissance des exigences de conformité FDA 21 CFR 820 et ISO 13485.
• Expérience en conception déquipements et de gabarits en développement de systèmes dessais et en validation de procédés.
• Maîtrise de LabVIEW et/ou de la programmation C/C pour lautomatisation des essais.
• Expérience avec SolidWorks pour la conception de gabarits mécaniques.
• Connaissance des systèmes dautomatisation ou des automates programmables industriels (API/PLC).
• Expérience avec les outils danalyse 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 déquipements 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 --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 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!