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 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

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

• Bachelors or masters 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 dessais 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 dessai et maintient léquipement spécialisé utilisé pour les activités de vérification de la conception. Le titulaire du poste travaillera en étroite collaboration avec les équipes dingénierie 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 dassurer le bon déroulement des opérations.
• Gérer linventaire des gabarits dessai 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 léquipe Qualité pour coordonner létalonnage et la maintenance préventive des équipements dessai (oscilloscopes analyseurs de spectre alimentations électriques etc.).
• Maintenir des dossiers précis sur lutilisation des équipements leur état détalonnage et leur historique de maintenance.
• Faire preuve dun engagement prioritaire envers la sécurité des patients et la qualité des produits en respectant la politique de qualité et lensemble 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 dessai 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 --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 dessaisposition 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 dessaisposition.

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.