Amanda Low Email & Phone Number

Aliso Viejo, Ca, Us

Aliso Viejo, California, United States

Aliso Viejo, California, United States

During my 1st rotation with a 6-month duration, I worked in the Regulatory Affairs department as well as the Project Management department. In my Regulatory Affairs rotation, I collaborated with 8 team members to develop an animal study strategy for the aspiration catheters portfolio by negotiating with the FDA through a pre-submission meeting, saving the company over $1M. Furthermore, I submitted a new license Health Canada submission for a Class IV clot retrieval device, and executed the submission of a Class Is device, Aspiration Kits, to comply with MDR regulations. Moving on to my Project Management rotation, I managed 50 highly visible process and test method validation projects for neuroendovascular therapy devices involving 60+ cross-functional team members, in response to FDA Form 483, by spearheading the project timeline developments and monitoring progress to completion. In addition, I took on a quality engineering project and revised 800+ risk control measures in a pFMEA by leveraging 23 MPs, as well as updating severities to align with an SOP update.

Riverside, California, United States

I gained experience twice a week using industrial lathe, milling, and welding machines from an expert with 40+ years of experience. Furthermore, I also facilitate 24 students as they master their machining skills while providing verbal technical feedback.

Aliso Viejo, California, United States

During my internship, I conducted design verification and validation on Class III coil assist stents to meet regulatory needs and complete design control. Root cause analysis was also one of the tasks I assisted with. I performed root cause analysis on the tensile strength of the stent introducer and created a solution for it. Furthermore, I performed competitive testing and presented results and terminology to the marketing and sales team successfully. I also created 26 models, drawings, and assemblies for fixtures, components, and sub-assemblies of flow diverting stent’s introducer.

Pomona, California, United States

During this internship, I helped accelerate the change in computerized system by migrating and converting 200+ documents from existing systems while exceeding the weekly document count required. Through this experience, I gained exposure to validation protocols (IQ, OQ, PQ), SOPs, and risk assessment documents for computerized systems.

Riverside, California, United States

My classmate and I took the initiative to create a research project with the guidance of the Assistant Dean of the College of Engineering. The goal for this research project is to remove nitrates from water by treating it meticulously with different cost-efficient methods. We decided to focus on nitrates because they are one of the major chemical contaminants in drinking water in many countries, especially Southeast Asia. We collaborated and researched many academic publications to explore various techniques for the removal and analysis of nitrates, keeping in mind to create a feasible test that we can perform in the school lab. We would then report a summary of our findings to faculty to get advice on our progress. We look forward to a test being chosen in the near future.

Riverside, California, United States

I serve 400+ international students yearly by organizing events ranging from 10 to 1000 attendees to spread cultural awareness and promote inclusion and diversity. To do that efficiently, I delegate my workload amongst five other interns through efficient communication and structured organization.

Riverside, California, United States

Throughout the year, I continuously enhanced the department’s marketing page on Instagram by using different tools, such as Canva, Adobe Lightroom, and Linktree, to create a more interactive and cohesive-looking page. Some accomplishments are that I created a new and official logo for the international department, designed a team uniform, and created social media graphics and posters for all of the events.

Riverside, California, United States

I aided with setting up events, ranging from small department meetings to events over 5,000 attendees. This job pushed me to maximize collaboration in a team and pay attention to details in order to satisfy our customer’s needs.

Bachelor Of Science - Bs, Chemical Engineering, Gpa: 4.0

Activities and Societies: Society of Women Engineers Club, American Institute of Chemical Engineers Club, Choir, Intramural Sports.

High School Diploma, Gpa: 4.1

Activities and Societies: National Honors Society, Varsity Basketball, Varsity Soccer, Varsity Track and Field, Choir, Show Choir, Jazz.