Job Description

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 ideal Senior Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative cardiovascular products. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

Your responsibilities will include:

Develops understanding of Design Controls, Risk Management and Usability for Medical Devices. Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling). Provide quality and compliance input for post market product sustaining activities, such as design changes, NCEP's, CAPA's PIRs, Field Signals Evaluations and Field Actions. Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements. Builds quality into all aspects of work by maintaining compliance to all quality requirements. Support internal and external regulatory audits as required. Other duties as necessary or required by the organization.

Required qualifications:

Bachelor's degree in mechanical, electrical, or biomedical engineering, or equivalent. 7+ years of work experience relating to quality assurance in a highly regulated industry. Medical device experience Competent with use of Microsoft Office Suite

Preferred Qualifications

Focus on detailed work with emphasis on accuracy and completeness Excellent organizational and planning skills; drives for results Strong communication (oral and written) and presentation skills High energy problem solver capable of driving items to closure Ability to collaborate and work on a global team

A propos du poste

L'ingenieur principal en assurance de la qualite de la conception ideal exerce son leadership dans le cadre de projets de developpement de nouveaux produits et de projets de soutien pour nos produits cardiovasculaires novateurs. En outre, il developpe, etablit et assure la mise en oeuvre de methodologies, de systemes et de pratiques d'ingenierie appliques a l'assurance de la qualite qui repondent aux exigences de BSC, des clients et des autorites de reglementation.

Responsabilites

Comprendre les controles de conception, la gestion des risques et la facilite d'utilisation des dispositifs medicaux. Fournir des informations sur la qualite et la conformite aux equipes responsables des projets en ce qui concerne les decisions a prendre et les produits livrables (c'est-a-dire l'analyse des changements relatifs a la conception, les donnees d'entree de la conception, les donnees de sortie de la conception, les methodes d'essai, les revues de la conception, la verification et la validation de la conception, les essais de facilite d'utilisation, la validation des logiciels, la validation des processus et l'etiquetage). Fournir des informations sur la qualite et la conformite pour les activites de soutien des produits apres leur mise sur le marche, telles que les modifications de la conception, les evenements de non-conformite, les besoins d'information prioritaires concernant les actions correctives et preventives, les evaluations des signaux sur le terrain et les actions sur le terrain. Appliquer des competences techniques, y compris des methodologies eprouvees et systematiques de resolution des problemes pour identifier, hierarchiser, communiquer et resoudre les problemes de qualite. Collaborer au sein d'une equipe afin d'identifier et de mettre en oeuvre des controles efficaces pour soutenir le developpement ou la maintenance des produits afin de repondre aux exigences internes et externes. Integrer la qualite dans tous les aspects du travail en maintenant la conformite a toutes les exigences de qualite. Soutenir les audits reglementaires internes et externes, le cas echeant. Executer d'autres taches requises ou exigees par la societe.

Competences requises

Baccalaureat en genie mecanique, electrique ou biomedical dans un domaine ou equivalent Plus de 7 ans d'experience professionnelle en matiere d'assurance de la qualite dans un secteur hautement reglemente Experience dans le domaine des dispositifs medicaux Maitrise de la suite d'applications Microsoft Office

Competences souhaitees

Capacite a se concentrer pour effectuer un travail minutieux en mettant l'accent sur l'exactitude et l'exhaustivite Excellentes capacites en matiere d'organisation et de planification; volonte d'obtenir des resultats Solides competences en matiere de communications (orales et ecrites) et de presentation Excellente capacite a resoudre les problemes et a mener les dossiers a terme Capacite a collaborer et a travailler au sein d'une equipe internationale

Requisition ID:

617682

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 Quality Design Assurance Engineer / ingenieur principal en assurance de la qualiteposition 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 Quality Design Assurance Engineer / ingenieur principal en assurance de la qualite 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.