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Design Controls Engineer
1 week ago
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.