Job Description

Additional Location(s): Canada-QC-MontrealDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 roleThe Senior R&D Systems Engineer will work alongside the R&D team to translate user needs into detailed design requirements and manage system specifications throughout the product development lifecycle. You will contribute to process improvements, 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, and systems engineering.Your responsibilities will include:

• Participates on project teams to translate user needs into design requirements (e.g. hardware, software, firmware, mechanical, electrical, interface, etc.) consisting of system/sub-system specifications.
• Manage system/sub-system requirements and generate requirements traceability.
• 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.
• Contributes to software/system risk assessment activities and uses Design FMEA\'s activities.
• Assists Regulatory with product submissions.
• Provides expertise and conducts evaluation of validation and verification activities.
• Assists with industry-based standards testing for safety and EMC according to 60601-1.
• Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables.

Required qualifications:

• B.Eng. / BS in Software 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.
• Extensive technical knowledge of advanced testing concepts and formal Software and Systems Verification strategies for regulated Software, preferably in the Medical Device Industry.

Preferred qualifications:

• At least 4 years of experience leading product development teams in a Medical Regulated Environment.
• 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.

Requisition ID: 588856As 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 \xc2\xa7 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.

Boston Scientific