Carrie Grant

Senior Engineer @Cook Medical

Lead Subject Matter Expert (SME) for Vascular Access Devices - Leading the Sustaining Engineering Efforts on EU MDR Tech File Certifications for Vascular Access Products - Project lead for Class EU MDR vascular access conformity tech file - Project lead for various continuous improvement activities for coil reinforced introducer design and manufacturing - Subject Matter Expert (SME)/Sustaining Reviewer for 510(k), EU MDR, Design Control, and Post-Market/Sustaining Documentation including User Needs (UN), Design Input Requirements (DIR), Verification and Validation (V&V); Failure Modes and Effects Analysis (FEMA) for Design, Process, and Usability; Hazard Analysis, Benefit Risk Analysis, Clinical Effects Analysis, Risk Management Plan & Report, and Technical Analyses - Project advisor and consultant for multiple vascular access EU MDR tech files - Frequently work cross-functionally with Regulatory CAPA; Labeling Assurance; QA; Quality, Supplier, Supplier Quality, Manufacturing, Process, and Validation Engineering; Product Management - Ensure compliance with regulatory requirements, internal Quality System, ISO, and other industry standards - Lead a team of 5 contractors to support 510(k) submissions and deficiency responses