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 role

The Senior R&D Specialist will liaise with various engineering stakeholders to analyze, develop, modify, and apply standards for system and software verification and validation methods. Furthermore, they will interpret company policies and procedures to resolve issues related to biomedical application.

Your responsibilities will include:

• Defines and analyzes system requirements, clinical workflows, and input/output processes by using current systems engineering methods and technologies.
• Solve system problems by analyzing the situation and recommending corrective or alternative actions.
• Documents system architecture and design control elements by writing documents, reports, and memos.
• Design and develop test plans and protocols to ensure designs meet requirements.
• Collaborates in the translation of customer needs into technical requirements, engaging the field, marketing, service, and other functions as needed.
• Supports the risk analysis for the project.
• Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables.
• Ensures compliance of project deliverables to GSM and supports system owners during external audits.
• Works independently to plan and schedule own activities necessary to meet timelines and communicate in a timely manner.

Required qualifications:

• Undergraduate or master\'s degree in engineering or related field.
• 5+ years of demonstrated experience in product development and design.
• Strong documentation skills.

Preferred Qualifications

• Technical knowledge of testing concepts for electromechanical equipment.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Knowledge of ISO 14971.
• Knowledge of IEC 60601 series of standards.
• Work experience preferably in a highly regulated environment
• Self-starter with the ability to quickly learn about new processes
• Strong problem-solving skills in a team environment.
• An analytical and quantitative approach to work, as well as the confidence to influence people at all levels.
• Excellent organizational, planning, communication, and collaboration skills.

Requisition ID: 562547

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!

Boston Scientific