R&D Test Lab Lead / chef du laboratoire d'essais

Additional Location(s): 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

The Test Lab Lead is responsible for coordinating and overseeing laboratory operations that support the verification of medical devices. This role ensures compliance with stringent regulatory standards, manages test environments, and maintains specialized equipment used for design verification activities. Working closely with engineering and quality teams, the Test Lab Lead ensures that all devices meet safety, performance, and reliability requirements before clinical or commercial release.

Your Responsibilities Will Include

• Oversee day-to-day laboratory activities to ensure smooth and efficient operations.
• Manage inventory of test fixtures, measurement instruments, and consumables.
• Enforce electrical safety and ESD protocols during all testing activities.
• Develop and enforce laboratory protocols, workflows, and SOPs.
• Conduct regular safety audits and provide safety training for laboratory staff.
• Supervise and mentor lab technicians, providing guidance on testing practices and equipment usage.
• Foster effective collaboration between design engineering and verification teams.
• Partner with Quality to coordinate calibration and preventive maintenance of laboratory test equipment (oscilloscopes, spectrum analyzers, power supplies).
• Maintain accurate records of equipment usage, calibration status, and service history.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.

Minimum Qualifications

• Bachelor’s or master’s degree in biomedical engineering, electrical engineering, or a related technical field.
• Strong understanding of medical device verification methodologies and regulatory requirements.
• Strong organizational, leadership, and laboratory coordination skills.
• Excellent communication and problem-solving abilities.

Preferred Qualifications

• Technical knowledge of testing concepts for electrical and electro-mechanical equipment.
• Knowledge of ISO 13485, IEC 60601, and FDA design control standards.
• Familiarity with risk management principles per ISO 14971.
• Hands-on experience with electrical safety testing and biocompatibility testing.

À propos du poste

Le chef du laboratoire d’essais est responsable de la coordination des activités du laboratoire soutenant la vérification des dispositifs médicaux. Ce rôle assure la conformité aux normes réglementaires strictes, supervise les environnements d’essai et maintient l’équipement spécialisé utilisé pour les activités de vérification de la conception. Le titulaire du poste travaillera en étroite collaboration avec les équipes d’ingénierie et de qualité afin de garantir que tous les dispositifs respectent les exigences en matière de sécurité, de performance et de fiabilité avant leur mise en clinique ou leur commercialisation.

Vos responsabilités comprendront

• Superviser les activités quotidiennes du laboratoire afin d’assurer le bon déroulement des opérations.
• Gérer l’inventaire des gabarits d’essai, des instruments de mesure et des consommables.
• Faire respecter les protocoles de sécurité électrique et de protection contre les décharges électrostatiques (ESD) pendant les essais.
• Élaborer, maintenir et appliquer les protocoles, les procédures opérationnelles normalisées (PON) et les processus du laboratoire.
• Mener des audits de sécurité réguliers et offrir des séances de formation au personnel du laboratoire.
• Encadrer et superviser les techniciens de laboratoire.
• Favoriser la collaboration entre les équipes de conception et les équipes de vérification.
• Travailler avec l’équipe Qualité pour coordonner l’étalonnage et la maintenance préventive des équipements d’essai (oscilloscopes, analyseurs de spectre, alimentations électriques, etc.).
• Maintenir des dossiers précis sur l’utilisation des équipements, leur état d’étalonnage et leur historique de maintenance.
• Faire preuve d’un engagement prioritaire envers la sécurité des patients et la qualité des produits, en respectant la politique de qualité et l’ensemble des processus et procédures documentés.

Qualifications minimales

• Baccalauréat ou maîtrise en génie biomédical, génie électrique, génie mécanique ou dans un domaine technique connexe.
• Solide compréhension des méthodologies de vérification des dispositifs médicaux et des exigences réglementaires applicables.
• Excellentes compétences en organisation, en leadership et en coordination de laboratoire.
• Excellentes aptitudes en communication, en collaboration et en résolution de problèmes.

Qualifications souhaitées

• Connaissance technique des concepts d’essai pour les équipements électriques et électromécaniques.
• Connaissance des normes ISO 13485, IEC 60601 et des exigences de la FDA en matière de contrôle de la conception.
• Familiarité avec la gestion des risques selon la norme ISO 14971.
• Expérience pratique en essais de sécurité électrique et en essais de biocompatibilité.

Requisition ID: 619633

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 R&D Test Lab Lead / chef du laboratoire d'essaisposition 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 R&D Test Lab Lead / chef du laboratoire d'essais 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.