Principal Design Quality / Qualité de conception principale

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

The ideal Principal Design Quality 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

propos du poste

L'ingnieur principal en assurance de la qualit de la conception idal exerce son leadership dans le cadre de projets de dveloppement de nouveaux produits et de projets de soutien pour nos produits cardiovasculaires novateurs. En outre, il dveloppe, tablit et assure la mise en uvre de mthodologies, de systmes et de pratiques d'ingnierie appliqus l'assurance de la qualit qui rpondent aux exigences de BSC, des clients et des autorits de rglementation.

Responsabilits

• Comprendre les contrles de conception, la gestion des risques et la facilit d'utilisation des dispositifs mdicaux.
• Fournir des informations sur la qualit et la conformit aux quipes responsables des projets en ce qui concerne les dcisions prendre et les produits livrables (c'est--dire l'analyse des changements relatifs la conception, les donnes d'entre de la conception, les donnes de sortie de la conception, les mthodes d'essai, les revues de la conception, la vrification et la validation de la conception, les essais de facilit d'utilisation, la validation des logiciels, la validation des processus et l'tiquetage).
• Fournir des informations sur la qualit et la conformit pour les activits de soutien des produits aprs leur mise sur le march, telles que les modifications de la conception, les vnements de non-conformit, les besoins d'information prioritaires concernant les actions correctives et prventives, les valuations des signaux sur le terrain et les actions sur le terrain.
• Appliquer des comptences techniques, y compris des mthodologies prouves et systmatiques de rsolution des problmes pour identifier, hirarchiser, communiquer et rsoudre les problmes de qualit.
• Collaborer au sein d'une quipe afin d'identifier et de mettre en uvre des contrles efficaces pour soutenir le dveloppement ou la maintenance des produits afin de rpondre aux exigences internes et externes.
• Intgrer la qualit dans tous les aspects du travail en maintenant la conformit toutes les exigences de qualit.
• Soutenir les audits rglementaires internes et externes, le cas chant.
• Excuter d'autres tches requises ou exiges par la socit.

Comptences requises

• Baccalaurat en gnie mcanique, lectrique ou biomdical dans un domaine ou quivalent
• Plus de 7 ans d'exprience professionnelle en matire d'assurance de la qualit dans un secteur hautement rglement
• Exprience dans le domaine des dispositifs mdicaux
• Matrise de la suite d'applications Microsoft Office

Comptences souhaites

• Capacit se concentrer pour effectuer un travail minutieux en mettant l'accent sur l'exactitude et l'exhaustivit
• Excellentes capacits en matire d'organisation et de planification; volont d'obtenir des rsultats
• Solides comptences en matire de communications (orales et crites) et de prsentation
• Excellente capacit rsoudre les problmes et mener les dossiers terme
• Capacit collaborer et travailler au sein d'une quipe internationale

Requisition ID: 604156

Minimum Salary: $95600

Maximum Salary: $189800

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).

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!