Design Assurance Engineer II - Electrophysiology

Additional Locations: Canada-ON-Mississauga; Canada-ON-Toronto

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At 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

Our team is growing, and we are currently looking for a Design Assurance Engineer II to join our Design Assurance team. This position works closely with New Product Development and Product Life Cycle teams to ensure risk management is applied, adequate design controls are met, and subsequent production and process controls are adequate.

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
• 2+ 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
  
  

Learn More About Our Transseptal Access Devices

Click this link to explore the groundbreaking technology behind our transseptal access devices at Boston Scientific: Transseptal access devices

Requisition ID: 591138

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!