Sr Design Assurance Engineer — Medical Device Design Controls Risk Management, Regulatory Compliance5+ years employed in the medical device industry. Experience in leading cross functional teams from R&D to manufacturing Guiding New Project Wins thru design verification and validation. Excellent skills in risk management documents: FMEAs and Hazard Analysis Quality issues investigation, Root Cause Investigation of CAPA/RCA Extensive background in Product Design/Prototyping Adhering to ISO 13485.2016 / CE standards Improved on statistical methods, validation techniques to conform with industry standards while even improving product quality