Senior Systems Engineer - Electrophysiology
Montreal, QC, CA
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 Senior R&D Systems Engineer will work alongside the R&D team to iterate on existing commercial products and perform new product development activities. The Senior R&D Systems Engineer will develop system architectures and translate user needs into detailed sub-system requirements throughout the product development lifecycle. You will contribute to process improvements (customer experience, manufacturing and servicing), conduct risk assessments, and support regulatory submissions, ensuring compliance with industry standards. This role involves close collaboration with cross-functional teams to evaluate and validate systems, drawing on your deep understanding of hardware, software/firmware, and systems engineering.
Your responsibilities will include:
- Participate in developing system architectures for existing and new product developments.
- Assess feasibility of new technologies prior to a new product development project through research, bench studies and pre-clinical evaluation.
- Participates on project teams to translate user needs into design requirements (e.g. system, hardware, software, firmware, mechanical, electrical, interface, etc.) consisting of system/sub-system specifications.
- Manage system/sub-system requirements and generate requirements traceability.
- Contributes to product risk assessment activities and perform Design FMEA’s activities.
- Assists Regulatory with product submissions.
- Provides expertise and helps evaluate the required validation and verification activities in a given project.
- Performs systems engineering in compliance with Basic Safety & Electromagnetic Compatibility according to 60601-1 (Basic Safety for Medical Devices)
- Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables.
- Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.
Required qualifications:
- Bachelor or Masters of Electrical, Biomedical, Mechanical or Firmware Engineering, or equivalent.
- 4+ years of experience with product development activities in a regulated industry.
- Experience in Systems Engineering and Systems Verification activities.
- Experience with authoring and analyzing requirements.
- Experience in troubleshooting test failures.
- Strong problem-solving skills in a team environment.
- Excellent organizational, communication and collaboration skills.
- Understanding of hardware design and trade-offs, embedded (real-time) software tradeoffs, performance, and redundancy issues.
Preferred qualifications:
- At least 4 years of experience leading product development teams in a Medical Regulated Environment.
- Experience in performing FDA Medical Device Submissions
- Experience in performing EU MDR Medical Device Submissions
- Experience in performing Japan Medical Device Submissions
- Understanding of signal processing.
- Experience in working on medical devices used in electrophysiology such as therapy or diagnostic devices (ablation and mapping systems).
- Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
- Knowledge of ISO 14971.
- Demonstrated ability to interact with and influence key stakeholders both internal and external to the organization.
À propos du poste
L’ingénieur principal en systèmes de R. et D. travaille avec l’équipe de R. et D. pour transposer les besoins des utilisateurs en exigences conceptuelles détaillées et gérer les cahiers des charges des systèmes tout au long du cycle de développement des produits. Il contribue à l’amélioration des procédés, mène des évaluations des risques et apporte son soutien aux demandes en matière de réglementation en veillant au respect des normes de l’industrie. Le titulaire de ce poste doit collaborer étroitement avec des équipes interfonctionnelles pour évaluer et valider les systèmes en s’appuyant sur ses connaissances approfondies du matériel, des logiciels et de l’ingénierie des systèmes.
Responsabilités
- Participer aux activités des équipes de projet pour transposer les besoins des utilisateurs en critères de conception (c.-à-d. matériel, logiciels, micrologiciels, mécanique, électricité, interfaces, etc.) énoncés sous la forme de cahiers des charges pour les systèmes et les sous-systèmes.
- Gérer les exigences des systèmes et des sous-systèmes et assurer la traçabilité de celles-ci.
- Améliorer en permanence les procédés et les méthodes de travail (en appliquant les principes Agile/Lean pour éliminer le gaspillage) afin de contribuer à la résolution de problèmes complexes et interdisciplinaires, et ce, en assurant l’interface avec les pairs et les groupes interfonctionnels.
- Contribuer aux activités d’évaluation des risques associés aux logiciels et aux systèmes et utiliser les activités d’AMDE de conception.
- Aider l’équipe responsable des questions liées à la réglementation à préparer les demandes relatives aux produits.
- Fournir une expertise et procéder à l’évaluation des activités de validation et de vérification.
- Collaborer aux essais relatifs aux normes industrielles en matière de sécurité et de compatibilité électromagnétique, conformément à la norme 60601-1.
- Travailler avec une équipe interfonctionnelle et représenter la R. et D. sur les produits livrables interfonctionnels.
Compétences requises
- Baccalauréat ou maîtrise en génie des logiciels ou des micrologiciels ou l’équivalent.
- Au moins quatre années d’expérience dans le domaine du développement de produits au sein d’un secteur réglementé.
- Expérience dans les domaines de l’ingénierie et de la vérification de systèmes.
- Expérience dans les domaines de la rédaction et de l’analyse des exigences.
- Expérience dans le domaine des tests de diagnostic.
- Excellentes aptitudes en matière de résolution de problèmes dans un environnement d’équipe.
- Excellentes aptitudes en matière d’organisation, de communication et de collaboration.
- Compréhension de la conception et des compromis en matière de matériel, des compromis en matière de logiciels intégrés (en temps réel), du rendement et des problèmes de redondance.
- Connaissance technique approfondie des concepts de test avancés et des stratégies de vérification officielle des logiciels et des systèmes pour les logiciels réglementés, de préférence dans le secteur des dispositifs médicaux.
Compétences souhaitées
- Au moins quatre années d’expérience dans le domaine du développement de produits dans un environnement médical réglementé.
- Connaissance approfondie des normes ISO 13485 et FDA 21, CFR Part. 820.
- Connaissance de la norme ISO 14971.
- Capacité avérée à interagir et à influencer les principales parties concernées, tant à l’intérieur qu’à l’extérieur de l’entreprise.
Requisition ID: 588856
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!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
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Systems Engineer, Biomedical Engineering, Testing, R&D Engineer, Medical Device, Engineering, Technology, Healthcare