Workstream technical lead for structural heart, TAVR implant.

Structural HeartTechnical Team Lead for Next Generation WATCHMAN LAAC implant and delivery system.Core team R&D lead for commercial support of WATCHMAN LAAC implant, delivery system, and access sheath.

New Product Development - Structural HeartSustaining R&D Lead

New Product Development - Peripheral Intervention, Drug Coated Balloon

Aortic Intervention Division- EndograftsCAPA− Owner of global CAPA on coating for Class III devices. Facilitated manufacturing implementation of corrective action for over 50 devices’ delivery systems in stages following regulatory approvals.− Completed root cause analysis and developed test methods on global CAPA for Class III devices’ delivery system. Built and tested 100’s of subassemblies to optimize process without compromising design outputs. Designed, fabricated, and developed new production fixtures and tooling and modifying current designs based upon testing results. Maintained lab notebook and binder of all test results and critical photos to the investigation.− Updated 11 risk documents, examined complaints, and coordinated with marketing, production, and global offices’ Regulatory Affairs and Engineering personnel on changes, testing, and implementation.Process Validation− Completed 4 process validations in 3 months. Determined validation scope and process independent/dependent variables based on relevant ISO standards and feasibility builds and testing. Performed IQ, facilitated OQ/PQ builds, implemented new equipment and process changes, and trained production staff. Wrote OQ/PQ protocols, reports, and process validation summaries for each validation. Wrote test protocol and completed design verification deployment testing in anatomical model for a device recall. Trained production staff on new inspection procedures for a critical deviation involving Class III devices.Completed Techfile dFMEA/pFMEA updates with global offices and facilitated responses to submission inquiries.Implemented Material Specification for material used on Class III devices for regulatory purposes.

Lean Projects (Scrap Reduction and Inspection Time Savings)− Saved Incoming Quality Assurance $90k annually by reducing sample sizes and moving testing to the supplier for 100 part numbers in less than 1 month.Process Development− In support of a newly released Guide Extension Catheter, created test capability for manufacturing, documented test method and trained technicians. Eliminated 2 hours of conditioning and up to 10 hours of manufacturing time.Quality Optimization Projects− Established supplier change tracker for Boston Scientific’s global suppliers. Communicated with 15 BSC employees at 10 BSC sites to track over 10 supplier changes and brought ownership into BSC. The tracker template will be used by the Global Improvement Team for an additional 10 suppliers− As part of a recent company acquisition, assessed 117 components for inspection readiness as part of the integration into Incoming Quality Assurance− SAP Quality Module Scoping- As part of a $14M quality optimization project, assessed 2 years’ worth of incoming receipts to generate a critical part list with over 1400 part numbers, which was used as the basis for implementing the SAP Quality Module at the Maple Grove facility.

I have worked 5 summers as a paraprofessional for special education elementary aged kids. I also spent two months as a math tutor in the High School and was in charge of "In School Suspension" a few times.