Jeonghee Lee Email & Phone Number

Saint Paul, MN, US

• RTS is an FDA-accredited Third-Party Review Organization (3PRO) that is authorized to review 510(k) submissions for selected low-to-moderate risk medical devices (Class II Medical Devices).
• Review 510(k) submissions for selected low-to-moderate risk medical devices (Class II Medical Devices).
• Training on ISO standards, FDA standards (e.g. ISO 14000 Series, ISO 10993, ISO 62304, ISO 13485, 21 CFR 820)
• Experience in reviewing Device Product codes for Class II devices (e.g. DSB, NUH, NGX, CAW, DXN)
• Manage Multiple concurrent projects, ensuring timely completion.
• Plan, schedule, and coordinate project tasks and activities.** Current List of FDA-recognized 510(k) Third Party Review can be found:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfthirdparty/accredit.cfm?party_key.

Abbott Park, Illinois, US

1. Preparation of User Requirement Specifications (URS) of each process equipment & Conduct a Risk Assessment for equipment and facility2. Review and revise detailed engineering documents (Detailed Design Specifications, Functional Specifications) & Fabrication drawings3. Design Equipment/System by utilizing Solidworks and(or) AutoCAD4. Generate.

Milwaukee, WI, US

Attended the Rockwell Automation Fair and received "Certificates of Completion" by attending several seminars (Nov 20 -21)

Maumee, Ohio, US

*Nominated for Malott Innovation and Engineering Excellence Competition*Purdue University Company-sponsored Senior Design Project Electric Brake Test Stand Redesign1. Redesign a Motor/Gear Support of Brake Test Stand by utilizing SolidWorks and CAM.2. Build a National Instrument (NI) based compact RIO (cRIO) Control System by utilizing LabView.3. Updating.

West Lafayette, Indiana, US

Energy and Transport Sciences Laboratory (ETSL)1. Exploring the electrochemical properties of Lithium-ion cells under normal and anomalous operating conditions.2. Fabricating the sample Lithium-ion Batteries applying the Coin Cell Assembly Methods in the Argon-Filled Glove Box.3. Working on the experimental data acquisition, post-processing the data and.

West Lafayette, Indiana, US

Inverted Pendulum ProjectA rod is mounted on a cart whose axis of rotation is perpendicular to the direction of a cart.A Cart is balancing the inverted pendulum for at least 30 seconds.NI myRIO and LABVIEW have been used for the project. Final System Demonstration is shown in the following video.

West Lafayette, Indiana, US

Autonomous Vehicle Design1. Structure around a microcontroller by National Instruments, called myRIO.2. Utilize LabVIEW software to design systems with graphical user interfaces.3. Build and Control Robots with PID control system4. Implement jitter, resource optimization, and embedded field programmable gate array (FPGA) Control

West Lafayette, Indiana, US

Center for Particulate Products and Processes (CP3)1. Operating the instruments in continuous line during experimental runs in and recorded any manual metadata.2. Processing and simulating the recorded experimental data of powder packings by utilizing MATLAB3. Assisting during the pre-processing stage and fabricating the essential equipment by using tools.

Design Good Now is a hackathon created to explore the benefits of industrial designers, bringing engineering and design together to create products that benefit specific disabilities. Our group took on the challenge of creating concepts that are specially tailored to aiding those suffering from Parkinson's Disease. The product is a highly functional device.

West Lafayette, Indiana, US

1. Focus on Visualization, Sketching, graphics standards and problem-solving strategies for engineering design.2. Demonstrate proficiency using 3D Computer-aided design process.

Bachelor Of Science (B.S.), Mechanical Engineering

Graduate Certificate, Medical Device Development

Education record

Education record