Boston Scientific is looking for a Design Quality Assurance Engineer to join the Design Assurance team within our Structural Heart Valves division. You will apply your engineering expertise to ensure patient safety and product excellence, supporting new product development and commercialized products that improve patient care. You will contribute to design strategy, risk management, and lifecycle quality activities while partnering with cross-functional teams.
What You'll Do
- 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.
What We're Looking For
- 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 Have
- 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.
Team & Environment
You will be part of the Design Assurance team within the Structural Heart Valves division, partnering with cross-functional teams in R&D, manufacturing, regulatory, and clinical.
Benefits & Compensation
- Compensation range: $82,100-$156,000
Work Mode
This is an onsite position based in Carlsbad, California.
Boston Scientific is an equal opportunity employer.
