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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. As a key member of our team, you will work closely with New Product Development teams to ensure risk management is applied and to ensure adequacy design controls as well as production and process controls.
Your Responsibilities:
- Collaborate with cross-functional teams to identify and implement effective controls to support development and maintenance of products to meet internal and external requirements.
- 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 standard practices and industry developments.
- Support departmental, functional, and divisional design quality goals and priorities.
- Embed quality into all aspects of work by maintaining compliance to all quality requirements.
- Participate in various design quality assurance and compliance improvement projects.
Required Qualifications:
- Bachelor's degree in Biomedical Engineering, Mechanical, Electrical Engineering, or a related field of study.
- 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/verbal communication skills.
- Ability to travel (less than 25%).
Preferred Qualifications:
- Knowledge of ISO 13485, ISO 14971, and IEC 60601.
- Medical imaging experience.
About Boston Scientific:
As a leader in medical science for over 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.
