Jeonghee Lee

Jeonghee Lee Email and Phone Number

Staff Engineer, reviewer at RTS @ REGULATORY TECHNOLOGY SERVICES
Jeonghee Lee's Location
Greater Minneapolis-St. Paul Area, United States, United States
About Jeonghee Lee

I am an accomplished professional with a robust background in mechanical engineering, having earned my degree from Purdue University. My academic journey has been complemented by a specialized focus on medical device development and regulatory affairs, delving into the intricacies of FDA-related regulations and ISO standards.Proudly registered and certified as an engineer by the Indiana Board, I bring a wealth of knowledge and expertise to the field. Currently calling the vibrant state of Minnesota home, I serve as a Staff Engineer and hold the esteemed position of Reviewer at RTS. RTS, an FDA-accredited third-party review organization, has entrusted me with the responsibility of evaluating 510(k) submissions for selected low-to-moderate risk medical devices, specifically those falling under Class II.With a rich professional history spanning three years in the industry, I am embarking on my fourth year with a passion for innovation and a commitment to ensuring the highest standards of quality and compliance in the medical device realm. My journey is marked by a dedication to merging mechanical engineering prowess with a profound understanding of regulatory landscapes, making me a valuable asset in the dynamic and evolving field of medical device development.

Jeonghee Lee's Current Company Details
REGULATORY TECHNOLOGY SERVICES

Regulatory Technology Services

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Staff Engineer, reviewer at RTS
Jeonghee Lee Work Experience Details
  • Regulatory Technology Services
    Staff Engineer, Reviewer
    Regulatory Technology Services Oct 2023 - Present
    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=4
  • Abbott
    Computer Aided Design Designer
    Abbott Sep 2022 - Oct 2022
    Abbott Park, Illinois, Us
  • Oh Pharmaceutical Co., Ltd.
    Associate Technical Engineer
    Oh Pharmaceutical Co., Ltd. 2019 - 2022
    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 Mechanical/ Electrical Bills of Materials(BOM) and Input/Output list5. Utilize Programmable Logic Controller (PLC) for the basic control of machine system - Basic Ladder Logic Programming - Sequential Function Chart (Pin Chart) + Sequence Programming - Input Output mapping - HMI Design & Interface with PLC - Basic Servo / Stepper Control
  • Rockwell Automation
    Trainee
    Rockwell Automation Nov 2019 - Nov 2019
    Milwaukee, Wi, Us
    Attended the Rockwell Automation Fair and received "Certificates of Completion" by attending several seminars (Nov 20 -21)
  • Dana Incorporated
    Prototype Engineer
    Dana Incorporated Jan 2019 - May 2019
    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 the driving motor with acceptable flexibility and accuracy.4. Apply calculation of brake requirements, brake systems, and control system results.
  • Purdue University College Of Engineering
    Research Assistant
    Purdue University College Of Engineering Aug 2018 - May 2019
    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 analysis.
  • Purdue University College Of Engineering
    System Integration And Test Engineer
    Purdue University College Of Engineering Feb 2019 - Apr 2019
    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.
  • Purdue University College Of Engineering
    Control System Designer
    Purdue University College Of Engineering Aug 2018 - Dec 2018
    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
  • Purdue University College Of Engineering
    Undergraduate Researcher
    Purdue University College Of Engineering Jan 2018 - May 2018
    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 from the machine shop
  • Designgoodnow
    Prototype Designer
    Designgoodnow Sep 2017 - Sep 2017
    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 that does not require any electronics or assembled mechanisms to easily open jars.
  • Purdue University College Of Engineering
    Computer Aided Design Engineer
    Purdue University College Of Engineering Aug 2016 - Dec 2016
    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.

Jeonghee Lee Skills

Menu Development Food And Beverage Leadership Administrative Hospitality Industry Hotel Management Banquet Operations Adobe Illustrator Food Service

Jeonghee Lee Education Details

  • Purdue University
    Purdue University
    Mechanical Engineering
  • University Of St. Thomas
    University Of St. Thomas
    Medical Device Development
  • Lowell Catholic High School
    Lowell Catholic High School
  • Cosby High School
    Cosby High School

Frequently Asked Questions about Jeonghee Lee

What company does Jeonghee Lee work for?

Jeonghee Lee works for Regulatory Technology Services

What is Jeonghee Lee's role at the current company?

Jeonghee Lee's current role is Staff Engineer, reviewer at RTS.

What schools did Jeonghee Lee attend?

Jeonghee Lee attended Purdue University, University Of St. Thomas, Lowell Catholic High School, Cosby High School.

What skills is Jeonghee Lee known for?

Jeonghee Lee has skills like Menu Development, Food And Beverage, Leadership, Administrative, Hospitality Industry, Hotel Management, Banquet Operations, Adobe Illustrator, Food Service.

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