Amanda Horiuchi
Salt Lake City,UT
Overview
7
7
years of professional experience
Work History
Quality Engineer II
Edwards Lifesciences
Draper, UT
01.2024 - Current
- Sustaining QE for Draper commercial launch of EVOQUE Delivery System and Accessories. Supporting EVOQUE NCR, CAPA, and complaint-related investigations
- Supporting RI NCR investigations and MRB for EVOQUE Delivery System and Accessories components
- Implemented labeling mistake proofing in boxing for EVOQUE Accessories CAPA
- Led Draper containment of ~55 WOs and X-Ray sort activities for EVOQUE DS complaint (tapered tip detachment)
- Owned SQE CAPA and SCARs to closure (or EM) as a result of SQE reorganization
Supplier Quality Engineer I
Edwards Lifesciences
Draper, UT
01.2023 - 01.2024
- Support site yield initiatives by ensuring defective components (Alterra, PDS, Advanced Catheters) were contained, and NCRs were closed in a timely manner
- Collaborated with suppliers, internal RI team, and sustaining manufacturing core teams to achieve stable RI acceptance rate metrics
- Received transfer of Draper in-house flex shaft components from NPD SQE team
- Owned SCARs (TE) to collaborate with the supplier to resolve quality issues and implement corrective and preventive actions
- Owned CAPA (Alterra) to update component drawing and create RI inspection fixture
BioDesign Graduate Teaching Assistant
University of Utah
Salt Lake City, UT
08.2021 - 05.2022
- Supported students on applying design control process to medical device innovation project
- Organized virtual, email, and in-person meetings to answer questions and mentor struggling students
- Coordinated budget, purchasing, and receiving of prototype supplies for 20 teams
- Provided timely grading and feedback to 75 students on assignments to assess student performance
Engineering Intern
Edwards Lifesciences
Draper, UT
05.2021 - 08.2021
- Coordinated multiple sites’ receiving inspection (RI) leaders to standardize metrics to drive global consistency and component site transfer efficiency using LeanKit and MS Power BI tools
- Designed and programmed a Draper MS Power BI dashboard to report weekly/monthly lead time, volume lots in vs lots out, and lots work in progress (WIP) to establish a RI metric reporting standard for all sites
- Created MS Excel queries to calculate inspection time and lot count for user-specified Draper BU(s) to identify workload drivers and plan for growth
- Performed historical receipt data analysis to define impact of 100% inspection on receiving inspection workload and proposed cost surcharge model to finance team leadership to account for uneven cost allocation
- Reviewed and prepared 200+ NCR Quality System Records forms for archival; ensuring files met GDP requirements
Undergraduate Research Assistant
Dr. Junco Warren Lab
Salt Lake City, UT
10.2018 - 04.2021
- Performed experiments following time and temperature sensitive procedures, wrote experimental protocols, conducted statistical analysis utilizing problem-solving skills to enhance project aims, and communicated findings with cross-functional teams
- Responsible for budget and inventory management, ordering, and receiving of items required for experiments
- Developed technical writing skills to communicate findings to general scientific audience
- Oka Si, Sabry AD, Horiuchi AK, Cawley KM, O’Very SA, et al. (2020) Perm1 regulates cardiac energetics as a downstream target of the histone methyltransferase Smyd1. PLOS ONE 15(6): e0234913
Education
BS/MS - Biomedical Engineering
University of Utah
Salt Lake City, UT05.2022
Projects
bioInnovate I & II: NeoTec SmoothRide Platform / University of Utah / 2021-22
- Collaborated with Univ. of Utah AirMed to reduce brain hemorrhaging in preterm neonates after emergency transport
- Team leader of multidisciplinary team of 5 to identify user needs, design specifications, develop a prototype, and perform verification tests
- Awarded milestone funding at Univ. of Utah Center for Medical Innovation (CMI) Bench to Bedside health care innovation competition to support translation of engineered design to business landscape viability
Timeline
Quality Engineer II
Edwards Lifesciences
01.2024 - Current
Supplier Quality Engineer I
Edwards Lifesciences
01.2023 - 01.2024
BioDesign Graduate Teaching Assistant
University of Utah
08.2021 - 05.2022
Engineering Intern
Edwards Lifesciences
05.2021 - 08.2021
Undergraduate Research Assistant
Dr. Junco Warren Lab
10.2018 - 04.2021
BS/MS - Biomedical Engineering
University of Utah
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