Medical Device Engineering

Jeremy Lim

*** ********, ******, ** ***** Phone: 484-***-**** Email: ********@***.***

EDUCATION

UNIVERSITY OF CALIFORNIA, IRVINE June 2020

Bachelor of Science in Biomedical Engineering GPA 3.468

Minor in Materials Science Engineering

EXPERIENCE

ADAGIO MEDICAL, INC Laguna Hills, CA 10/2019 – present

Engineering Intern (40 hours/week)

Executed validation protocols for equipment and fixture Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) and used Minitab to perform Gage R&R and statistical analysis.

Executed cleanroom production line time studies and data driven process improvement in a lean event using Six Sigma Green Belt principles to reduce variances of production assembly process.

Designed and prototyped various tools and fixtures for medical device sub-assembly using SolidWorks and additive manufacturing to make components.

Responsible for conducting Device Verification Testing including device lifecycle testing, mechanical testing, and tissue testing using pig heart muscle.

Composing executive summaries of results to inform on device performance and offer potential improvements.

Responsible for performing microscopic visual inspections of device parts using Keyence VHX digital microscope.

Responsible for managing quality documents to be in compliance with FDA and ISO standards.

Responsible for managing Design History File for ongoing medical device project.

Authored and revised quality documents including product specifications, design requirements, work instructions, production travelers, HAs, QVPs, IPs, NMRs, CAPAs, and SOPs.

Responsible for keeping inventory of all components of medical device project, interacting with manufacturers and suppliers for quotes, and create purchase orders using QuickBooks.

TOMBOLA LAB UC Irvine 04/2019 – 12/2019

Research Assistant

Executed experimental protocols including PCR, restriction digest, cell culture, spectroscopy and provided statistical analysis on voltage-gated proton channel Hv1.

ALLERA MEDICAL Irvine, CA 09/2019 – 12/2019

Engineering Intern (UCI CO – OP)

Designed and prototyped a benchtop fixture to perform characterization study for product development.

Authored requirements document, down selection chart, design inputs, experimental protocols, and MATLAB algorithms for characterizing optimal combinations of wavelengths for best spatial resolution of vasculature in human forearms of varying skin tones using near infrared light.

NASA JET PROPULSION LABORATORY Pasadena, CA 01/2014 – 5/2014

Intern

Executed experimental protocols including sub-culturing microbial isolates, DNA extraction, PCR, gel electrophoresis for microorganism samples collected from Mars-based spacecrafts.

Archived 5000 microorganism samples collected from Mars-based spacecrafts using Excel and sorted the file for bioinformatician to upload into online database.

SKILLS

Good computer skills with knowledge of Microsoft Office, SolidWorks (CSWA certified), MATLAB, LabVIEW, and Minitab.

Strong verbal and written communication skills, including the ability to make effective and persuasive presentations.

Demonstrated ability to work effectively in a highly charged, fluid environment.

Very detail-oriented, well-organized, and driven to meet deadlines and project goals.

Good knowledge in Medical Devices (i.e. catheters), Research and Development (R&D), Design Control, and ISO 13485, Design of Experiments (DOE), Validation and Verification, and Six Sigma.

A self-starter with the ability to work with any cross-functional team.

Self-motivated to pursue personal development including Six Sigma, Minitab, and other PDUs.

Contact this candidate