Senior Engineer, R&D Sustainment

Innovation starts from the heart. At Edwards, we put patients first and invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease.

This is an on-site role based at our corporate headquarters in Irvine, CA. The selected candidate must reside in the local region.

How you will make an impact:
The Senior Engineer, R&D Sustaining Engineer will support lifecycle management of on-market Class III medical devices by investigating field and manufacturing issues, implementing design and process improvements, supporting engineering change assessments, and ensuring continued product safety, performance, reliability, manufacturability, and regulatory compliance.

• Issue Resolution and Root Cause Investigation: Lead investigations and resolve device field issues by analyzing product performance data, customer feedback, and failure reports. Define and execute engineering studies and testing to determine root cause and support effective actions to minimize device downtime and customer impact.
• Design and Process Improvement: Collaborate with cross-functional teams, including R&D and manufacturing, to identify and lead the implementation of innovative solutions including design changes and process improvements that enhance device reliability, performance, and manufacturability.
• Product Performance Monitoring: Continuously monitor and assess device performance and quality metrics. Develop and execute plans to address deviations from expected performance and support sustained product performance.
• Design Changes & Change Control: Lead design and process changes for on-market medical devices, including design impact assessments, design documentation updates, requirement and specification updates, verification planning, implementation through change control processes, and assessment of potential impacts to labeling and risk.
• Risk Management: Lead risk management activities including updates to design FMEAs, hazard analyses, and risk management files. Evaluate whether identified issues, process changes, or design changes introduce new hazards, impact existing risk controls, or require additional mitigation, verification, or validation.
• Verification and Validation (V&V): Develop, review, and execute engineering test plans, protocols, reports, and test methods to support product changes, manufacturing improvements, complaint investigations, CAPAs, and regulatory responses. Analyze results using appropriate engineering and statistical methods and ensure objective evidence supports technical conclusions and design change decisions.
• Documentation and Compliance: Maintain accurate and comprehensive documentation of engineering changes, investigation records, technical reports, test records, risk documentation, and change control documentation. Ensure all activities comply with regulatory requirements and company standards.
• Cross-Functional Collaboration: Work closely with manufacturing, quality assurance, regulatory affairs, clinical development, suppliers, and other engineering teams to support product lifecycle management and ensure effective implementation of engineering solutions.
• Other Duties: Perform other duties as assigned.

• Bachelor’s Degree in Engineering or Scientific field with 4 years of experience.
• Master’s Degree or equivalent in Engineering or Scientific field with 3 years of experience.
• Ph.D. or equivalent in Engineering or Scientific field.
• Experience with ISO 13485, ISO 14971, FDA quality management system regulations, and applicable medical device regulatory expectations.
• Experience developing or executing verification and validation protocols, engineering test methods, and technical reports.
• Knowledge of medical device design controls, change control, CAPA, complaint investigations, and risk management.
• Proficiency in engineering software and statistical tools related to design and data analysis, in particular Python, Minitab, and Excel.
• Strong written and verbal communication skills with the ability to clearly document technical rationale and present findings to…