Job Description

Additional Locations: Canada-ON-Mississauga; Canada-ON-Toronto
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
Our R&D Engineer II will join our Access Solutions' Franchise to lead the development of our next generation transseptal puncture technology. The role will be involved in all aspects of the design and development process for Medical Device programs. This individual will have the opportunity to work in a high-paced, cross-functional, and collaborative environment.
Please note that this is a 12-month contract role
Your responsibilities will include:

• Support complex cutting-edge medical device systems through prototyping, testing and modeling.
• Develop device design history files (i.e., requirements, risk management, usability files.
• Ensure compliance to industry and international standards.
• Develop verification and validation plans, protocols, and reports.
• Perform independent tests, studies, analyses, and interpretations to generate technical conclusions and provide recommendations.
• Conduct work across the full scope of technical and documentation activities for the department.
• Make independent studies, analyses, interpretations, and conclusions.
• Responsible for technical input into project level planning.
• Provide technical guidance to review work plans and advise on unusual features of projects
• Provide technical, project level leadership to engineering assistants or junior engineering staff.
• Participate in failure investigations and repair planning.
• Assist in DFM (Design for Manufacturing) activities.
• Develop and test new manufacturing processes.
• Support regulatory filings to various government bodies as required.
• Support the development of intellectual property where required.
• Support pre-clinical and clinical research activities? where required.
• Other duties as required.

Required Qualifications

• Bachelor's Degree in Engineering (Biomedical, Mechanical preferred)
• 2+ years of related working experience from a regulated manufacturing industry
• 2+ years of relevant design control experience
• Experience with the overall design and development process

Preferred Qualifications

• Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607
• Self-starter with the ability to quickly learn about new processes
• Excellent analytical and communication skills (both written and oral)
• Able to work independently and in a multidisciplinary team environment

Learn more about our Transseptal Access Devices
Click this link to explore the groundbreaking technology behind our transseptal access devices at Boston Scientific:
Requisition ID: 616885
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) 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!

Skills Required