Senior Design Assurance Engineer

4 weeks ago

Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full time

About Boston Scientific Gruppe

We're a global leader in medical technology, dedicated to improving patient outcomes and transforming healthcare. Our team is passionate about innovation, diversity, and collaboration, and we're committed to making a positive impact on people's lives.

Job Summary

We're seeking a Senior Design Assurance Engineer to join our Interventional Cardiology division. As a key member of our team, you'll play a critical role in ensuring the quality and safety of our products, from concept to commercialization.

Key Responsibilities

  • Support the execution and documentation of Design Validation & Verification and Usability activities.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
  • Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
  • Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Lead and support cross-functional root-cause analysis investigation and resolution activities.
  • Evaluate and support design test and inspection method development, and lead method validation activities.
  • Support regulatory submissions to notified bodies.
  • Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Requirements

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related field of study.
  • 5+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience.
  • Problem solver, capable of facilitating the problem-solving process.
  • Adaptable and effective collaborator in a team environment and in self-directed work.
  • Demonstrated use of Quality tools/methodologies.

Preferred Qualifications

  • Ability to work in a highly matrixed and geographically diverse business environment.

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