Job 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.

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.

A propos du poste :

En tant qu'ingenieur principal en essais R&D, vous contribuerez a la conception, a la validation et a l'amelioration continue des systemes d'essais pour les dispositifs medicaux de pointe de Boston Scientific. Dans ce role, vous ferez partie de l'equipe en pleine croissance des equipements capitaux en electrophysiologie (EP), responsable du developpement et de l'execution d'activites completes de verification et de validation pour des systemes electriques et electromecaniques complexes.

Vos responsabilites comprendront :

Analyser les exigences du systeme et de la conception afin de developper des plans d'essais, des protocoles et des rapports complets garantissant que les conceptions respectent toutes les specifications et normes. Appliquer vos connaissances techniques pour concevoir, developper et valider des methodes d'essai, des procedes, des gabarits et/ou des systemes d'automatisation. Effectuer des essais d'ingenierie, fonctionnels et de performance sur des composants, sous-systemes et systemes electromecaniques complets. Surveiller et analyser les resultats d'essais, rediger des rapports techniques detailles et formuler des recommandations pour ameliorer la conception et la fabricabilite. Fournir des commentaires en matiere de conception pour la fabricabilite (DFM) et de conception pour les essais (DFT) lors des revues de conception et de developpement. Diriger ou soutenir les activites de validation d'equipement et de procede (IQ/OQ/PQ) dans le cadre du systeme de qualite. Collaborer avec des equipes interfonctionnelles, incluant R&D, Qualite, Fabrication et Affaires reglementaires, afin d'assurer l'alignement avec les exigences de conception et de procede. Fournir des conseils techniques, du mentorat et, au besoin, de la formation aux techniciens ou au personnel d'essai pendant les activites de validation ou de developpement. Demontrer un fort engagement envers la securite des patients et la qualite des produits en respectant la politique de qualite et les procedures de Boston Scientific.

Qualifications requises :

Baccalaureat en genie electrique ou dans un domaine connexe. Plus de 6 ans d'experience en developpement de produits ou de systemes dans une industrie reglementee. Excellente comprehension des principes d'ingenierie et de resolution de problemes, ainsi que des notions de base de la validation des essais et de la gestion du changement. Experience pratique dans le developpement et l'execution d'activites de verification et validation (V&V) pour des systemes electriques ou electromecaniques. Capacite a developper des solutions creatives et fondees sur les donnees, et a collaborer efficacement au sein d'equipes d'ingenierie multidisciplinaires. Solides competences analytiques, organisationnelles et en documentation. Excellentes aptitudes en communication et en collaboration. Capacite demontree a prendre des initiatives, a identifier des occasions d'amelioration et a les mener a terme. Resilience face aux defis, avec une planification efficace des risques et de solides competences en resolution de problemes.

Qualifications preferees :

Experience dans l'industrie des dispositifs medicaux, avec une connaissance des exigences de conformite FDA 21 CFR 820 et ISO 13485. Experience en conception d'equipements et de gabarits, en developpement de systemes d'essais et en validation de procedes. Maitrise de LabVIEW et/ou de la programmation C/C++ pour l'automatisation des essais. Experience avec SolidWorks pour la conception de gabarits mecaniques. Connaissance des systemes d'automatisation ou des automates programmables industriels (API/PLC). Experience avec les outils d'analyse statistique et la prise de decision fondee sur les donnees (p. ex. Minitab, JMP). Experience dans les processus de developpement de nouveaux produits, particulierement dans les systemes electromecaniques ou d'equipements 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 / ingenieur 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 / ingenieur principal en essais R&D position.



However, in Quebec, 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!