Jeonghee Lee
Greater Minneapolis-St. Paul Area,MN
Summary
Detail-oriented, organized and meticulous employee. Works at fast pace to meet tight deadlines. Enthusiastic team player ready to contribute to company success.
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
5
5
years of professional experience
6
6
years of post-secondary education
3
3
Certifications
3
3
Languages
Work History
Staff Engineer, Reviewer
Regulatory Technology Services (RTS)
St Paul, MN
10.2023 - Current
- RTS is 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)
- Training on 510(k) submissions, ISO standards, regulations
- Managed multiple concurrent projects, ensuring timely completion and adherence to budget constraints.
- Presented technical findings and recommendations to key stakeholders with clarity, supporting informed decision-making processes.
- Facilitated effective team collaboration by establishing clear goals and expectations, leading to higher morale and increased productivity.
- Performed and documented quality control checks to maintain compliance with company initiatives
- Prioritized project-related tasks to efficiently complete essential tasks
CAD Designer (Contract Position)
Abbott
Plymouth, MN
09.2022 - 10.2022
- Primary function of MCAD Designer/Drafter is to support MCAD data migration project
- Reconciling all SolidWorks CAD files in preparation for loading them into company's PDM system
- Locate, visualize, and verify quality system drawing PDF matches latest SolidWorks drawing file.
- Reviewed specifications to generate complex details of individual system components
- Managed multiple concurrent projects efficiently, ensuring timely delivery without compromising quality standards
- Rendered schematics for over 150 designs in Solidworks to produce 2D and 3D models.
- Collaborated with cross-functional teams to optimize project outcomes through effective communication and CAD expertise
Associate Technical Engineer
OH PHARMACEUTICAL, CO.
Merrillville, IN
09.2019 - 07.2022
- Preparation of User Requirement Specifications (URS) of each process equipment and send them to potential vendors to get technical proposal
- Preparation of Documents that are required for medical device submission (510 (k)) to FDA
- Conduct Risk Assessment for equipment and facility based on GMP/ cGMP guidelines
- Produced reports on success rates and remedial requirements.
- Identified and corrected system faults to minimize operational system downtime.
- Provided secondary training to personnel struggling with technological tools and systems.
- Monitored ongoing technical compliance with applicable laws and regulations.
- Worked with governance committees to make and evaluate plans.
- Streamlined regulatory processes for increased efficiency in submitting medical device applications to FDA.
Education
Graduate Certificate - Medical Device Developments
01.2022 - 05.2023
Bachelor of Science - Mechanical Engineering
01.2015 - 05.2019
Skills
Bilingual (English Korean)
Certification
FE Mechanical Engineering
Locations
Greater Minneapolis-St. Paul Area, MN
Timeline
Staff Engineer, Reviewer - Regulatory Technology Services (RTS)
10.2023 - Current
CAD Designer (Contract Position) - Abbott
09.2022 - 10.2022
University of Saint Thomas - Graduate Certificate, Medical Device Developments
01.2022 - 05.2023
Associate Technical Engineer - OH PHARMACEUTICAL, CO.
09.2019 - 07.2022
Purdue University - Bachelor of Science, Mechanical Engineering
01.2015 - 05.2019
FE Mechanical Engineering
Engineer in Training
Autodesk AutoCAD User Certification - Autodesk Korea
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