Boston Scientific Design Assurance Engineer III - Electrophysiology 

Canada, Ontario, Mississauga 

477336041

Canada-ON-Mississauga; Canada-ON-Toronto

Your responsibilities will include:

• Responsible for design control and risk management activities.
• Managing and updating product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs
• Collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Using clinical knowledge/Data to influence how devices you are working on are tested and designed.
• Applying technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Identifying and driving continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.
• Building quality into all aspects of work by maintaining compliance to all quality requirements.
• Planning, organizes and prioritizes own daily work routine to meet established schedule.
• Utilizing standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• In all actions, demonstrating 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.

Required qualifications:

• Bachelor's Degree in Biomedical Engineering, Mechanical, Electrical Engineering or related field of study
• 3+ years related working experience from Medical Device Industry
• Knowledge of ISO 13485, ISO 14971
• 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

Preferred qualifications:

• Six Sigma problem solving methodologies
• Training experience to FDA regulations or ISO standards