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 be responsible for designing, executing, and improving test processes that ensure the safety, quality, and performance of Boston Scientific's innovative medical technologies. Working within the Electrophysiology (EP) Capital Equipment division, you will plan and perform verification and validation activities for our cutting-edge medical devices, with a particular focus on cable assemblies and related hardware.
Your responsibilities will include:

• Analyzing system and design requirements to develop test plans, protocols, and reports that verify design compliance.
• Designing and conducting engineering, functional, and performance testing for electrical and electro-mechanical assemblies.
• Coordinating test article shipments and tracking progress through sterilization, packaging, and mechanical reliability test flows.
• Reviewing and approving test documentation to ensure accuracy, completeness, and consistency.
• Supporting troubleshooting and failure investigations, compiling and analyzing test data to identify root causes and recommend improvements.
• Developing and maintaining test fixtures, procedures, and automation tools to support testing efficiency.
• Communicating with vendors and external partners regarding test scheduling, documentation, and equipment logistics.
• Ensuring all activities comply with Boston Scientific's Quality Policy and relevant regulatory requirements (FDA, ISO 13485).
• Providing technical guidance and training to technicians or test personnel as required.
• Planning and prioritizing individual work to meet deadlines and project milestones with minimal supervision.

Required qualifications:

• Bachelor's degree in electrical engineering or a related technical field.
• 5+ years of experience in product or system development within a regulated industry.
• Strong understanding of engineering and problem-solving principles, test validation, and change management.
• Hands-on experience in developing and executing V&V tests for electrical or electro-mechanical systems.
• Excellent documentation, organizational, and communication skills.
• Demonstrated ability to work independently, manage multiple priorities, and drive tasks to completion.
• Commitment to product quality and patient safety through rigorous testing and validation.

Preferred qualifications:

• Experience in the medical device industry, with knowledge of FDA 21 CFR 820 and ISO 13485 requirements.
• Experience in equipment and fixture design, test system development, and process validation.
• Proficiency with LabVIEW and/or C/C++ programming for automated testing.
• Experience using SolidWorks for designing test fixtures or mechanical components.
• Familiarity with automation systems and programmable logic controllers (PLCs).
• Experience performing data analysis or statistical evaluations using tools such as Minitab or JMP.
• Exposure to new product development processes, particularly for capital equipment or electro-mechanical devices.

A propos du poste :
En tant qu'ingenieur principal en essais R&D, vous serez responsable de la conception, de l'execution et de l'amelioration des processus d'essais afin d'assurer la securite, la qualite et la performance des technologies medicales novatrices de Boston Scientific. Au sein de la division des equipements capitaux en electrophysiologie (EP), vous planifierez et realiserez des activites de verification et de validation pour nos dispositifs medicaux de pointe, en mettant particulierement l'accent sur les assemblages de cables et les composants materiels connexes.
Vos responsabilites comprendront :

• Analyser les exigences du systeme et de la conception afin d'elaborer des plans d'essais, des protocoles et des rapports permettant de verifier la conformite de la conception.
• Concevoir et executer des essais d'ingenierie, fonctionnels et de performance pour des assemblages electriques et electromecaniques.
• Coordonner l'expedition des articles d'essais et assurer le suivi de leur progression a travers les etapes de sterilisation, d'emballage et d'essais de fiabilite mecanique.
• Examiner et approuver la documentation d'essais afin d'en garantir l'exactitude, l'exhaustivite et la coherence.
• Soutenir les activites de depannage et d'enquete sur les defaillances, en analysant les donnees d'essais pour identifier les causes fondamentales et recommander des ameliorations.
• Developper et entretenir les gabarits d'essai, les procedures et les outils d'automatisation afin d'optimiser l'efficacite des essais.
• Communiquer avec les fournisseurs et partenaires externes concernant la planification des essais, la documentation et la logistique des equipements.
• Veiller a ce que toutes les activites respectent la politique de qualite de Boston Scientific ainsi que les exigences reglementaires applicables (FDA, ISO 13485).
• Fournir un encadrement technique et une formation au personnel technique ou aux techniciens, au besoin.
• Planifier et prioriser les activites individuelles afin de respecter les echeanciers et les jalons de projet avec un minimum de supervision.

Qualifications requises :

• Baccalaureat en genie electrique ou dans un domaine technique connexe.
• Plus de 6 ans d'experience en developpement de produits ou de systemes dans une industrie reglementee.
• Solide comprehension des principes d'ingenierie, de resolution de problemes, de validation d'essais et de gestion du changement.
• Experience pratique dans la conception et l'execution d'essais de verification et de validation pour des systemes electriques ou electromecaniques.
• Excellentes competences en documentation, en organisation et en communication.
• Capacite demontree a travailler de facon autonome, a gerer plusieurs priorites et a mener les taches a terme.
• Engagement envers la qualite des produits et la securite des patients grace a une validation et des essais rigoureux.

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 les essais automatises.
• Experience avec SolidWorks pour la conception de gabarits d'essais ou de composants mecaniques.
• Connaissance des systemes d'automatisation et des automates programmables industriels (API/PLC).
• Experience en analyse de donnees ou en evaluations statistiques a l'aide d'outils tels que Minitab ou JMP.
• Exposition aux processus de developpement de nouveaux produits, particulierement dans le domaine des equipements capitaux ou des systemes electromecaniques.

Requisition ID: 615989
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 (Cables) / ingenieur principal en essais R&D (cables) 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 (Cables) / ingenieur principal en essais R&D (cables) 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!

Skills Required