R&D Engineer II

Additional Locations: Canada-ON-Mississauga; Canada-ON-TorontoDiversity - 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 role:This role is in the R&D Engineering team of the Access Solutions division.  This group is responsible for managing the complete lifecycle of products from ideation to market release and beyond. The group also serves new product development projects through concept generation, design, prototyping, and manufacturing transfer.  The engineer will work within a team of other engineers and supporting departments to compile, analyze, and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.  In addition, the engineer will 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:Fully participate in project teams to contribute the necessary technical work related to product design and development.Collaborate closely with manufacturing, process engineering, supplier engineering, and customer support teamsTechnical analysis of medical device systems and materials for existing products to ensure designs meet quality and regulatory standards.Gather requirements from internal and external sources to accurately capture user needs and ensure products are meeting themPerform technical analysis, investigate failure modes and perform root cause analyses for both new and existing products.Generate and review detailed engineering documentation (e.g. technical reports, DHF, DMR) and ensure compliance with quality systems and regulatory requirements.Assist in Design for Manufacturing (DFM) activitiesComply with the health and safety policies of the company and inform management of unsafe working conditionsOther duties as required. Required qualifications:Bachelor’s degree in Biomedical engineering, or equivalentMinimum 2-4 years related working experience, or equivalentExperience working within a quality management system and quality system controls (e.g. Design inputs/outputs, Verification/validation, etc.)Knowledge of the design requirements as per 21 CFR 820 and ISO 13485Candidates should be self-starters and have a hands-on approachAbility to work independently and within a diverse group of EngineersStrong communication skills (verbal/written) Preferred qualifications:Bachelor’s degree in Biomedical, Mechanical, or Electrical Engineering preferredExperience working within medical device R&D departments, with hands-on prototyping and testingFamiliarity with industry related standards (e.g. ISO, ASTM, ASME, IEC, etc.) and their applicationExperience with product lifecycle managementExperience with catheter devices developmentExperience with injection molding component designExperience with electrical medical device testing and development Learn more about our Transseptal Access DevicesClick this link to explore the groundbreaking technology behind our transseptal access devices at Boston Scientific: Transseptal access devices Requisition ID: 622856Minimum Salary: $59,900 Maximum Salary: $108,900  The anticipated compensation and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--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.  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