R&D Systems Engineer II / ingénieur II en systèmes de R et D

Additional Locations: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 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 industrys 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:

• 2 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.

propos du poste

Lingnieur II en systmes de R et D travaille avec lquipe de R et D pour transposer les besoins des utilisateurs en exigences conceptuelles dtailles et grer les cahiers des charges des systmes tout au long du cycle de dveloppement des produits. Il contribue lamlioration des procds mne des valuations des risques et apporte son soutien aux demandes en matire de rglementation en veillant au respect des normes de lindustrie. Le titulaire de ce poste doit collaborer troitement avec des quipes interfonctionnelles pour valuer et valider les systmes en sappuyant sur ses connaissances approfondies du matriel des logiciels et de lingnierie des systmes.

Responsabilits:

• Participer aux activits des quipes de projet pour transposer les besoins des utilisateurs en critres de conception (c.--d. matriel logiciel mcanique lectricit interface etc.) noncs sous la forme de cahiers des charges pour les systmes et les sous-systmes.
• Grer les exigences des systmes et des sous-systmes et assurer la traabilit de celles-ci laide dun outil de gestion des exigences.
• Participer llaboration des architectures de conception des systmes.
• Documenter et concevoir des protocoles de communication entre les diffrents sous-systmes (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 tudes sur banc dessai et rdiger des rapports techniques.
• Fournir une expertise en matire dactivits de validation et de vrification et procder celles-ci.
• Entreprendre et documenter des valuations des modifications de la conception pour les nouveaux produits et les produits bnficiant dun soutien.
• Grer et tenir jour le carnet de bord JIRA et hirarchiser les fonctionnalits mettre en uvre.
• Participer au rapprochement des modles de sous-systmes et lintgration des caractristiques au niveau des systmes.
• Travailler au sein dune quipe interfonctionnelle et reprsenter la R et D sur les produits livrables interfonctionnels.
• Amliorer en permanence les procds et les mthodes de travail (en appliquant les principes Agile/Lean pour liminer le gaspillage) afin de contribuer la rsolution de problmes complexes et interdisciplinaires et ce en assurant linterface avec les pairs et les groupes interfonctionnels.
• Avoir une solide comprhension des processus de contrle de la conception de lindustrie des dispositifs mdicaux.
• Autres tches selon les besoins.

Comptences requises:

• Diplme universitaire en gnie lectrique en gnie biomdical ou dans un domaine connexe.
• 2 annes dexprience dans le domaine du dveloppement de produits au sein dun secteur rglement.
• Exprience dans les domaines de lingnierie et de la vrification de systmes.
• Exprience dans les domaines de la rdaction et de lanalyse des exigences.
• Exprience dans le domaine des tests de diagnostic.
• Excellentes aptitudes en matire de rsolution de problmes dans un environnement dquipe
• Excellentes aptitudes en matire dorganisation de communication et de collaboration

Comptences souhaites:

• 2 annes dexpriencedans le domaine du dveloppement de produits dans un environnement mdical rglement.
• Comprhension de la conception et des compromis en matire de matriel des compromis en matire de logiciels intgrs (en temps rel) du rendement et des problmes de redondance.
• Connaissance technique approfondie des concepts de test avancs et des stratgies de vrification officielle des logiciels et des systmes pour les logiciels rglements de prfrence dans le secteur des dispositifs mdicaux.
• Connaissance approfondie des normes ISO13485 et FDA21 CFR Part. 820.
• Connaissance de la norme ISO14971.
• Capacit avre interagir et influencer les principales parties concernes tant lintrieur qu lextrieur de lentreprise.

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 the R&D Systems Engineer II 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 position.

However in Qubec 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.

Notre socit est prsente partout au Canada et est reprsente commercialement dans 140 pays.

Comme le titulaire de ce poste est amen collaborer rgulirement avec des collgues des clients et des interlocuteurs du Canada des tats-Unis et de ltranger la matrise de langlais est essentielle pour assurer une communication et une correspondance efficaces. La matrise de langlais est galement requise pour travailler avec toute une srie de documents et maintenir une communication efficace en cas dinteraction avec des clients ou des vendeurs externes.

Comme illustr dans la description des tches il implique notamment de communiquer oralement et par crit avec les autres quipes de Boston Scientific situes partout au Canada et avec nos clients et partenaires internationaux. En effet les clients et les partenaires internationaux reprsentent une partie importante de nos activits. la suite dune analyse nous avons dtermin que les tches lies au poste de lingnieur II en systmes de R et D ncessitent la connaissance de langlais en plus du franais ( loral et lcrit). Nous avons galement dtermin que la connaissance de langlais dj exige des autres employs ne permet pas lexcution des tches ncessitant la connaissance de langlais lies au poste de lingnieur II en systmes de R et D.

Cependant Boston Scientific restreint le plus possible le nombre de postes pour lesquels elle exige la connaissance dune autre langue que le franais. Boston Scientific nexige la matrise de langlais que lorsque cela est ncessaire lexcution des tches dun employ.

Requisition ID:607066

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).

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) isnt just business its personal. And if youre 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!