Senior R&D Engineer
Boston Scientific
- Mississauga, ON
- Permanent
- Full-time
- 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.
- Bachelor's Degree in Mechanical or Biomedical Engineering
- 5+ years of related working experience from a regulated manufacturing industry
- 4+ years of relevant design control experience
- Experience with the overall design and development process
- Experience focusing on R&D activities in the medical devices industry
- 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