Chloe Chung, Ph.D. Email & Phone Number

Memphis, Tennessee, United States

Memphis, Tennessee, United States

Memphis, Tennessee, United States

- Provided Navigation R&D support for the integration of spinal implants and instruments into Medtronic's surgical navigation platforms (StealthStation) and robotic guidance platform (Mazor X Stealth) via tools support package- Cross-functional tools package team lead for:- - - Quality review and maintenance of DHF documentation including system design and development documentation, product requirements, and verification test protocols and reports.- - - Product performance reviews of existing CAPAs, product defects, and FDA guidance to drive scope of new projects- - - Risk-based defect dispositioning and evaluation of potential hazards for usability and patient safety impact- - - Cross-site review of system and component level design and user Failure Mode and Effects Analyses for appropriate mitigations, requirement tracing, and supporting evidence- - - Hazardous situation reviews and assessment of the post-market probability of failure occurrence and harm for system malfunctions and design issues in navigated products- - - Stakeholder in development of new test cases and definition of input/output/acceptance criteria driven by product requirements and design while ensuring testability and clarity- - - Early lifecycle development of Mazor tools package product, which included establishing effective communications between multiple sites, the creation of a unique risk management architecture, integration of cross-site quality management systems- Capstone project team member for enriching Medtronic’s Software DRM Cyber Security Curriculum - Responsible for ensuring processes and quality management systems adhere to industry standards (21 CFR Part 820, ISO 14971 Risk Management, IEC 62304 Software Life Cycle Processes, ISO 13485 Quality Management Systems)

Memphis, Tennessee

- Performed biomechanical studies using a robotic testing platform, including the comparative analysis of various spinal implants and orthoses, as part of a central research objective to evaluate and develop new medical devices, surgical techniques, prosthetics, and orthotics - Responsibilities included most aspects of the biomechanical experiment design and execution, including the programming of a biorobotic testing platform, fabrication of custom test fixtures, cadaveric tissue preparation, data analysis and interpretation, technical report writing, literature review, and presentation of findings to a body of peers- Developed and implemented multiple clinical study protocols following Good Clinical Practice (GCP) guidelines to evaluate medical devices in clinical populations in collaboration with local hospitals and clinics- Served as the laboratory safety representative and was responsible for maintaining the safety manual and equipment, perform routine inspections, enforce safety rules within the lab, and ensuring all personnel remain up-to-date on mandatory training- Assisted PI in preparing grant proposals and patent applications- Presented findings to audiences at conferences and published manuscripts in peer-reviewed journals- Mentored research conducted by other graduate students in the laboratory and clinic

- Measurements and Instrumentation laboratory for the UTHSC Department of Biomedical Engineering- Functional Anatomy didactic lectures for the UTHSC Department of Biomedical Engineering- Gross Anatomy laboratory for the UTHSC Department of Anatomy and Neurobiology, Department of Physical Therapy, and Department of Occupational Therapy

Greater Memphis Area

- Participated in early stage product development and benchtop validation testing of the START brace (a device capable of applying traction to the lumbar spine while still allowing patients to perform daily living activities in a pain free environment)- Worked with manufacturers and suppliers to fabricate functional prototypes- Assisted in the design and implementation of a clinical trial of the START brace- Drafted a regulatory strategy to achieve product clearance adhering to applicable FDA and international regulations

Bartlett, Tn

- Assisted in the development and implementation of new processes which improved the quality and lowered the cost of various products and components;- Developed manufacturing specifications for several products, which required close interaction with line operators and thorough inspection of products;- Implemented of over 30 facility change orders

Greater Memphis Area

- Responsible for preparation of technical documents to be incorporated into aircraft certification and to maintain compliance with Federal Aviation Administration and FedEx requirements- Over the course of several months, drafted and released over 300 Engineering Authorizations which successfully prevented the FAA grounding of the FedEx 757 fleet- Led the effort in the rigid cargo barrier replacement on several FedEx 777 aircraft

Greater Memphis Area

- Responsibilities included aspects of testing protocol and report preparation, product testing, and data analysis- Created CAD models and drafted drawings for the development and design of spinal implants, instruments, and test fixtures- Performed an essential role in the release of a new product by building and testing over 390 constructs in various FDA mandated ASTM testing

Doctor Of Philosophy (Ph.D.), Biomedical Engineering (Biomechanics), 3.96

Activities and Societies: UTHSC Graduate Student Executive Committee: BME Representative, 2015 - 2016, 2019-2020 – Grant Awards – UT.

Master Of Science (Ms), Biomedical Engineering (Biomechanics), Gpa 3.95

Activities and Societies: Biomedical Engineering Society UM/UT Chapter: Liaison, 2014; UTHSC Graduate Student Executive Committee: BME.

Bachelor Of Science (Bs), Mechanical Engineering, Gpa 3.48

Activities and Societies: Recipient, CBU Buckman Scholarship, 2008 - 2012; Recipient, CBU Engineering Scholarship, 2008 - 2012; Recipient.

High School Diploma

Activities and Societies: Mu Alpha Theta, National Honor Society, Latin Honor Society, 2008 Regional Math Competition, Track and Field.