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Design Controls Engineer

1 week ago


Mississauga, Ontario, Canada Boston Scientific Gruppe Full time

Job Overview

We are seeking a highly skilled Design Assurance Engineer III to join our team at Boston Scientific Gruppe. As a member of our cross-functional team, you will play a crucial role in ensuring the quality and reliability of our medical devices.

Your Key Responsibilities

  • Manage and update product risk management files to ensure adequate design controls and risk management.
  • Collaborate with the team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
  • Use clinical knowledge/data to influence how devices are tested and designed.
  • Apply technical skills and sound problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Identify and drive continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.

Requirements

  • Bachelor's Degree in Biomedical/Mechanical Engineering or related field of study.
  • 3+ years of related work experience in design assurance, sustaining engineering, or related medical device experience.
  • ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Management.
  • Demonstrated interpersonal skills with ability to work within a team environment.
  • Able to work independently under limited supervision.

What We Offer

  • A dynamic and supportive work environment.
  • Ongoing training and development opportunities.
  • A competitive salary and benefits package.