Ph.D. with rich experience and proven capability in reliability engineering and quality compliance for development and manufacturing of class III medical devices:
• CAPA program leadership experience
• Root cause analysis expert and problem-solving skills
• Six Sigma project management experience
• Reliability engineering expert (Design for Reliability, FMEA, FTA, system reliability analysis, ALT/HALT, life data analysis, failure analysis)
• Energy storage technology experience
• Medical device pre-market product development experience
• Medical device post-market product surveillance experience
• Medical device product complaint trending experience
• Medical device quality