Eithne Mullen

Background

About Eithne Mullen

Experienced Design Quality/ Reliability engineer for both Pre-Market and Post-market class implantable devices and now class II wearable monitoring devices. In my current role as a Design Quality Engineer for iRhythm technologies I am responsible for design change impact assessments for wearable monitors, benefit/risk assessments and design control deliverables.Prior to this role, I held positions in - Pre Market Design Assurance supporting Mitral & Tricuspid Structural Heart group at Medtronic. My work focused on Risk Management and Design control deliverables such as FMECA, Product Hazard Analysis, Use/User error analysis, Design Validation & Verification studies and cleaning validation of reusable product designs- Post Market Design Assurance supporting the Medtronic Aortic business. Responsibilities of this role included Product Risk Assessments, Recall support, Complaints Trending, FMECA and risk management file monitoring/upkeep, Post Market Surveillance Reporting, Clinical Update/Annual Reporting review. Review of supplier and manufacturing product changes and lean sigma improvements- Supplier Quality Engineering. I executed the role of lead SQE to ensure all suppliers and components involved in a company acquisition met Medtronic QMS and regulatory requirements- Component Engineering. I executed the role of CE to draft and release component qualification reports and test method validation reports for a next generation pre-market CRHF device- Product Experience Management/Complaint Handling. I executed the role of US-MDR/ EU-Vigilance specialist responsible for complaint review and submission, Regulatory Authority query review and response. I also assisted with COS deployment and lean sigma improvement efforts.