Design Assurance Engineer

Duration: 12 Months Contract with Possible of extension Job Description As a Senior 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 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. Responsibilities 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. 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. #J-18808-Ljbffr