Canada-ON-Mississauga; Canada-ON-Toronto
Your responsibilities will include:
- Fully participating in project teams to contribute the necessary technical work related to product design and development.
- Technical analysis of medical device systems and materials for new product development and 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 them
- Investigate failure modes and perform root cause analyses
- Generate detailed engineering documentation (e.g. Technical reports, DHF, and DMR) in adherence to quality policies and systems.
- Innovate and create new concepts and designs for products and submit invention disclosures
- Assist in Design for Manufacturing (DFM) activities
- Comply with the health and safety policies of the company and inform management of unsafe working conditions
- Other duties as required.
Required qualifications:
- Bachelor’s degree in Biomedical engineering, or equivalent
- Minimum 2 years related working experience, or equivalent
- Experience 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 13485
- Candidates should be self-starters and have a hands-on approach
- Ability to work independently and within a diverse group of Engineers
- Strong communication skills (verbal/written)
Preferred qualifications:
- Bachelor’s degree in Biomedical, Mechanical, or Electrical Engineering preferred
- Experience working within medical device R&D departments, with hands-on prototyping and testing
- Knowledge of ultrasound imaging, particularly in cardiac applications
- Familiarity with industry related standards (e.g. ISO, ASTM, ASME, IEC, etc.) and their direct application
- Experience with catheter devices development
- Experience with injection molding component design
- Experience with electrical medical device testing and development
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.