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Design Assurance Engineer I
2 months ago
About the Role:
Boston Scientific is seeking a highly skilled Design Assurance Engineer I to join our Quality team. This position plays a critical role in ensuring the development and maintenance of medical devices meet internal and external requirements.
Your Key Responsibilities:
- Collaborate with cross-functional teams to identify and implement effective controls to support product development and maintenance.
- Develop a deep understanding of Design Controls, Risk Management, and Usability for Medical Devices.
- Apply repeatable problem-solving concepts to drive quality and compliance.
- Stay up-to-date with industry standards and best practices.
- Support departmental, functional, and divisional design quality goals and priorities.
- Ensure compliance to all quality requirements by maintaining a strong focus on quality throughout all aspects of work.
- Participate in various design quality assurance and compliance improvement projects.
- Perform other duties as necessary or required by the organization.
Required Qualifications:
- Bachelor's degree in Biomedical Engineering, Mechanical, Electrical Engineering, or a related field of study.
- At least 1 year of related work experience from the Medical Device Industry.
- Demonstrated interpersonal skills with the ability to work within a team environment.
- Strong written and verbal communication skills.
- Ability to travel (less than 25%).
Preferred Qualifications:
- Knowledge of Six Sigma problem-solving methodologies.
- Understanding of ISO 13485, ISO 14971, and IEC 60601 standards.
- Experience in medical imaging.