Design Quality Assurance Engineer
About The Position
Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. Apply your engineering expertise to ensure patient safety and product excellence by joining the Design Assurance team within our Structural Heart Valves division. As a Quality Design Assurance Engineer, you will support new product development and commercialized products that improve the delivery of care for patients around the world. In this role, you will contribute to design strategy, risk management and lifecycle quality activities while partnering with cross-functional teams in R&D, manufacturing, regulatory and clinical. You will work in a collaborative, high-performance environment that values innovation, accountability and continuous improvement.
Requirements
- Bachelor of Science degree in Engineering or a related technical field
- Minimum of 3 years' experience in quality engineering or design assurance within the medical device industry
- Experience supporting risk management, design controls and product verification and validation
- Knowledge of global quality system regulations and standards, including ISO 13485 and ISO 14971
- Strong written and verbal communication skills
- Ability to manage multiple priorities in a fast-paced environment
Nice To Haves
- Degree in biomedical or mechanical engineering
- Experience supporting cardiovascular or implantable medical devices
- Certification in quality engineering (e.g., CQE) or related credential
- Experience applying quality tools and statistical methodologies
- Demonstrated commitment to continuous improvement and collaboration
Responsibilities
- Apply systematic problem-solving methodologies to support resolution of product and process quality issues across the product lifecycle
- Provide quality engineering support on cross-functional new product development teams, ensuring robust design inputs, verification and validation activities and regulatory compliance
- Support risk management activities, including hazard analysis and FMEAs, ensuring alignment with ISO 14971 and internal standards
- Develop, review and approve verification and validation protocols and reports, ensuring compliance with applicable regulatory requirements
- Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs
- Support design change control activities, assessing product and process impacts to ensure compliance and patient safety
- Monitor field performance of medical devices, analyze trends and support corrective and preventive actions as needed
- Contribute to continuous improvement initiatives that enhance product quality and team effectiveness
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
