In this highly visible role, you will influence design strategy, risk management, and lifecycle quality activities while partnering with cross-functional leaders in R&D, manufacturing, regulatory, and clinical. You will thrive in a high-performance culture that values diversity, innovation, global collaboration and a winning spirit — where continuous learning and meaningful impact are part of every project.
Your responsibilities will include:
● 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 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.
Qualifications:
Required qualifications:
● 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.
● Proven ability to lead cross-functional initiatives and influence stakeholders at multiple organizational levels.
● Strong written and verbal communication skills.
● Ability to manage multiple priorities and navigate ambiguity in a fast-paced environment.
Preferred qualifications:
● 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.
● Passion for continuous improvement, talent development and building high-performing teams.
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