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 position
The R&D Systems Engineer II works with the R&D team to translate user needs into detailed design requirements and manage systems specifications throughout the product development lifecycle. They contribute to process improvements, conduct risk assessments, and support regulatory requests by ensuring compliance with industry standards. This role is expected to work closely with cross-functional teams to evaluate and validate systems using their extensive knowledge of hardware, software, and systems engineering.
Your responsibilities will include:

• Participate in project team activities to translate user requirements into design criteria (i.e. hardware, software, mechanical, electrical, interface, etc.) stated in the form of specifications for systems and subsystems.
• Manage system and subsystem requirements and ensure their traceability using a requirements management tool.
• Participate in the development of system design architectures.
• Document and design communication protocols between different subsystems (software, firmware and FPGA).
• Contribute to product risk management documentation - risk analysis, design FMEA and process FMEA.
• Conduct test bench studies and write technical reports.
• Provide expertise in and carry out validation and verification activities.
• Undertake and document design change assessments for new and supported products.
• Manage and maintain the JIRA backlog and prioritize features to be implemented.
• Participate in the reconciliation of subsystem models and the integration of features at the system level.
• Work within a cross-functional team and represent R&D on cross-functional deliverables.
• Continuously improve processes and working methods (applying Agile/Lean principles to eliminate waste) to contribute to the resolution of complex and interdisciplinary problems, while interfacing with peers and cross-functional groups.
• Have a solid understanding of the medical device industry's design control processes.
• Other duties as required.

Required qualifications:

• University degree in electrical engineering, biomedical engineering or a related field.
• 2+ years of experience in product development within a regulated sector.
• Experience in systems engineering and verification.
• Experience in the areas of requirements writing and analysis.
• Experience in the field of diagnostic testing.
• Excellent problem solving skills in a team environment
• Excellent organizational, communication and collaboration skills

Preferred qualifications:

• At least two years of experience in product development in a regulated medical environment.
• Understanding hardware design and tradeoffs, embedded (real-time) software tradeoffs, performance and redundancy issues.
• Deep technical knowledge of advanced testing concepts and formal software and system verification strategies for regulated software, preferably in the medical device industry.
• Extensive knowledge of ISO 13485 and FDA 21, CFR Part. 820 standards.
• Knowledge of ISO 14971 standard.
• Proven ability to interact and influence key stakeholders, both inside and outside the company.

A propos du poste
L'ingenieur II en systemes de R et D travaille avec l'equipe de R et D pour transposer les besoins des utilisateurs en exigences conceptuelles detaillees et gerer les cahiers des charges des systemes tout au long du cycle de developpement des produits. Il contribue a l'amelioration des procedes, mene des evaluations des risques et apporte son soutien aux demandes en matiere de reglementation en veillant au respect des normes de l'industrie. Le titulaire de ce poste doit collaborer etroitement avec des equipes interfonctionnelles pour evaluer et valider les systemes en s'appuyant sur ses connaissances approfondies du materiel, des logiciels et de l'ingenierie des systemes.
Responsabilites

• Participer aux activites des equipes de projet pour transposer les besoins des utilisateurs en criteres de conception (c.-a-d. materiel, logiciel, mecanique, electricite, interface, etc.) enonces sous la forme de cahiers des charges pour les systemes et les sous-systemes.
• Gerer les exigences des systemes et des sous-systemes et assurer la tracabilite de celles-ci a l'aide d'un outil de gestion des exigences.
• Participer a l'elaboration des architectures de conception des systemes.
• Documenter et concevoir des protocoles de communication entre les differents sous-systemes (logiciels, microprogrammes et FPGA).
• Contribuer au dossier de gestion des risques relatifs aux produits -- analyse des risques, AMDE de conception et AMDE de processus.
• Effectuer des etudes sur banc d'essai et rediger des rapports techniques.
• Fournir une expertise en matiere d'activites de validation et de verification et proceder a celles-ci.
• Entreprendre et documenter des evaluations des modifications de la conception pour les nouveaux produits et les produits beneficiant d'un soutien.
• Gerer et tenir a jour le carnet de bord JIRA et hierarchiser les fonctionnalites a mettre en oeuvre.
• Participer au rapprochement des modeles de sous-systemes et a l'integration des caracteristiques au niveau des systemes.
• Travailler au sein d'une equipe interfonctionnelle et representer la R et D sur les produits livrables interfonctionnels.
• Ameliorer en permanence les procedes et les methodes de travail (en appliquant les principes Agile/Lean pour eliminer le gaspillage) afin de contribuer a la resolution de problemes complexes et interdisciplinaires, et ce, en assurant l'interface avec les pairs et les groupes interfonctionnels.
• Avoir une solide comprehension des processus de controle de la conception de l'industrie des dispositifs medicaux.

Competences requises

• Diplome universitaire en genie electrique, en genie biomedical ou dans un domaine connexe.
• Deux annees d'experience dans le domaine du developpement de produits au sein d'un secteur reglemente.
• Experience dans les domaines de l'ingenierie et de la verification de systemes.
• Experience dans les domaines de la redaction et de l'analyse des exigences.
• Experience dans le domaine des tests de diagnostic.
• Excellentes aptitudes en matiere de resolution de problemes dans un environnement d'equipe
• Excellentes aptitudes en matiere d'organisation, de communication et de collaboration

Competences souhaitees

• Au moins deux annees d'experience dans le domaine du developpement de produits dans un environnement medical reglemente.
• Comprehension de la conception et des compromis en matiere de materiel, des compromis en matiere de logiciels integres (en temps reel), du rendement et des problemes de redondance.
• Connaissance technique approfondie des concepts de test avances et des strategies de verification officielle des logiciels et des systemes pour les logiciels reglementes, de preference dans le secteur des dispositifs medicaux.
• Connaissance approfondie des normes ISO 13485 et FDA 21, CFR Part. 820.
• Connaissance de la norme ISO 14971.
• Capacite averee a interagir et a influencer les principales parties concernees, tant a l'interieur qu'a l'exterieur de l'entreprise.

Requisition ID: 611432
Minimum Salary: $57200
Maximum Salary: $113700
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 Systems Engineer II / ingenieur II en systemes de R et D 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 R&D Systems Engineer II / ingenieur II en systemes de R et D 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!