Design Assurance Engineer III
Boston Scientific
- Mississauga, ON
- Permanent
- Full-time
- Responsible for design control and risk management of next-generation capital equipment devices.
- Uses clinical knowledge/Data to influence how devices they are working on are tested and designed.
- Responsible for the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
- Builds quality into all aspects of work by maintaining compliance to all quality requirements.
- Plans, organizes and prioritizes own daily work routine to meet established schedule.
- Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
- Apply technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Other duties as required.
- Bachelor's Degree in Engineering (Electrical or Biomedical preferred)
- 3+ years related working experience from Medical Device Industry
- Knowledge of ISO 13485, ISO 14971, IEC 62366-1, IEC 62304
- Demonstrated interpersonal skills with ability to work within a team environment
- Strong written/verbal communication skills
- Must be able to work independently under limited supervision
- Six Sigma problem solving methodologies
- Training experience to FDA regulations or ISO standards