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

We are currently seeking a Senior Research & Development Engineer to assist with the development of products. This role will have a focus on design and maintenance activities for a complex product family. Our engineers are involved in all aspects of the medical device development and maintenance including design, prototyping, manufacturing transfer, maintenance and service. These individuals also have an opportunity to work with the appropriate government bodies to obtain regulatory approval, and to issue patents in conjunction with the IP department.

Your responsibilities will include:

• Support complex cutting-edge medical device systems through prototyping, testing and modeling.
• Develop device design history files - Requirements, Risk Management, Usability Files.
• Ensure compliance to industry and international standards.
• Develop verification and validation plans, protocols, and reports.
• Lead or drive technical or systemic elements of ongoing or new projects.
• Ability to manage multiple high-priority projects simultaneously, ensuring that they are completed on time.
• Maintain technical support of regulatory activities, quality compliances, supplier changes, and cross functional support for the currently marketed products.
• 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.
• Responsible for technical input into project level planning. Conducts independent work 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\xe2\x80\x8b where required.
• Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.
• Other duties as required.

Required qualifications:

• Bachelor\'s degree in Engineering required
• 5+ years of relevant work experience
• Experience working inside a regulated industry with ISO 9000/9001/13485 quality management systems
• Knowledge of the design requirements as per 21 CFR 820 and ISO 13485
• Experience with drafting and maintaining DHF and DMR documentations
• Experience with leading rapid design iteration and making design recommendations
• Ability to independently develop and adapt work plans based on vague or changing project goals
• Strong hypothesis-driven experimental design and statistical analysis skills
• Demonstrated experience in creative engineering design
• Candidates should be self-starters and have a hands-on approach
• Ability to work independently and within a diverse group of Professional and Production staff
• Strong communication skills (verbal/written) and demonstrated leadership skills
• Commitment to serving customers and patients

Preferred qualifications:

• Bachelor\'s degree in Mechanical or Biomedical Engineering preferred
• Related experience in medical devices with a focus on capital equipment
• Experience with capital device development
• Experience with catheter devices development
• Experience with Solidworks, JAMA and Minitab

What we have to offer:

• Hybrid working model for many roles combining on-site and remote work, paired with flexible working hours.
• Comprehensive total rewards package, including bonus, RRSP or 401k employer matching, tuition reimbursement, health & dental benefits, and a health or lifestyle (your choice!) spending account.
• Generous paid time off, including vacation days, personal days, statutory holidays, and a Holiday shutdown!
• A strong commitment to mental health and well-being, including a company-paid meditation app, meditation rooms in some buildings, fully trained Mental Health First Aid staff members, and weekly yoga/HIIT/Pilates/mindfulness online professionally-led classes for all employees.
• Headquarters based roles offer functional outdoor spaces (bring your laptop to one of multiple wi-fi connected outdoor patios to work) and access to a beautiful ravine trail system for lunchtime walks
• Employer subsidized gourmet, high-quality, healthy meals available onsite, freshly delivered multiple times a week.
• Strong senior leadership commitment to Inclusion and Diversity; many opportunities to join I&D committees and spearhead I&D initiatives; employer-hosted roundtables with external experts, guest speakers and workshops/celebrations.
• Formal mentorship program, robust biweekly internal networking events and multiple communication streams open to senior management for all employees to provide continuous feedback
• Employee-friendly work environment, with opportunity to participate in employee-led clubs (for example, book club, French club, gardening club, rock climbing club, boardgame club, tea club), and support to create new clubs
• Employee recognition rewards platform (Guusto) - receive gift cards as recognition for a job well done!
• Formal leadership training programs for leaders and non-leaders to develop their careers
• Purposeful work that drives career development, with opportunities to learn and grow by way of on-site training, workshops, and lunch and learn sessions.
• Smart commute options including complimentary shuttle from Kipling Station, subsidized transit program and complimentary Electrical Vehicle charging on site.

Requisition ID: 558600

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