Design Quality Engineer

• Support new product development and commercialized products that improve the delivery of care for patients around the world.
• Lead and apply advanced, systematic problem-solving methodologies to resolve complex product and process quality issues across the product lifecycle.
• Provide senior-level quality engineering leadership on cross-functional new product development teams, ensuring robust design inputs, verification and validation strategies and regulatory compliance.
• Drive the implementation and continuous improvement of risk management activities, including hazard analysis, fault tree analysis and FMEAs, ensuring alignment with ISO 14971 and internal standards.
• Develop and approve verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements.
• Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection of readiness.
• Lead design change control activities, assessing product and process impacts while ensuring compliance and patient safety.
• Monitor field performance of new and established medical devices, analyze trends against risk assessments, and drive corrective and preventive actions as needed.
• Mentor junior engineers and contribute to the development of best practices that elevate team capability and performance.

• Bachelor of Science degree in Engineering or a related technical field.
• Minimum of 7 years' experience in quality engineering or design assurance within the medical device industry.
• Demonstrated expertise in risk management, design controls and product verification and validation.
• Strong knowledge of global quality system regulations and standards, including ISO 13485 and ISO 14971.
• Ability to manage multiple priorities and navigate ambiguity in a fast-paced environment.

Preferred:

• Degree in biomedical or mechanical engineering.
• Experience supporting structural heart, cardiovascular or implantable medical devices.
• Certification in quality engineering (e.g., CQE) or related credential.
• Demonstrated use of advanced quality tools and statistical methodologies