Anderson Milfort Cell: 786-***-**** Email: adgzbh@r.postjobfree.com

Education

Bachelor’s in biomedical engineering May 2019

Florida International University, Honors College

Work Experience

Regulatory Affairs Specialist May 2019-Dec 2020

Johnson and Johnson

• Prepared, and submitted global regulatory dossiers, US and International for new and existing products.

● Coordinate and assist in the maintenance of licenses and authorizations for existing products (e.g., US PMA, International Registrations, and Dossiers, updates to technical files), and device changes requests

● Provides Regulatory Affairs support during internal and external audits (as needed).

● Update Regulatory Affairs procedures as needed to comply with EU MDR Requirements.

● Coordinates and assists in the review and approval of new and/or revised product labeling to ensure regulatory compliance.

● Completed Regulatory Impact assessments for product, process and package changes and communicate results to the appropriate departments. Product Development Engineer October 2018 – May 2019 Hanger Clinic: Prosthetic and Orthotic

● Prepared summary technical and verification plan Documents to ensure device meet ISO, and ASTM standard

● Prepared and documented DHF and DMR for the project

● Developed Federal Regulation(FDA) Pathway using 510k, PMA filling processes and GDP for the project

● Modeled device’s drawings and assemblies using SolidWorks Computer aided design software(CAD)

● Worked within a 4 people team to developed project plan in Microsoft Project to ensure deadlines are met

● Implemented DFMEA & PFMEA to discover potential failure within the design process

● Lead in product verification and process validation activities (IQ/OQ/PQ) Research and Development Engineering Intern April 2018 – August 2018 Cardinal Health

● Designed fixtures using CAD and developed test setup for angioplasty catheter stent deployment testing

● Incorporated lean principles and make contribution maintain lab organization

● Participated in daily meeting with Manufacturing and Quality engineering team

● Write and review verification and validation protocol to complies with company standard

● Participated in the assemble, packaging and performed inspection test to ensure device meets company requirement.

Academic Project

Instructor (Lead)

● Developed and coordinated the optimal design of a lower limb prosthetic device that quantifies screw displacement of prosthetic socket to enable clinician to perform alignment

● Designed and built a temperature sensor and GUI interface using Arduino and MATLAB to provide real time temperature of patients and alert physicians of critical temperature changes

● Modeled and simulated motions of a robotic arm with 3D printed materials Leadership Experience

Senior Design Project Leader August 2018 – Present

● Responsible for organizing team meetings, contacting sponsors, and ensuring that deadlines are metyearlong. Facilitating and encouraging communication among the team and delegating tasks to members efficiently. Secretary of F.I.U.’s Honors College’s S.T.I.T.C.H. August 2016 – August 2018

● Served as the link between the organization and its members, ensuring their questions and concerns were being considered by the board. Coordinated and managed events and ensured constant communication between other board members.

Lesson of Life and Leadership Course August 2017 – December 2017

● Honors leadership course taught by Florida International University’s President Emeritus Dr. Modesto Maidique on the importance and impact of great leadership. Developed team building and leadership skills through a series of interactive lectures and exercises. Research Experience

Tissue Engineered Mechanics, Image and Materials

July 2017 – Present

● Performed mechanical testing to characterize the bending and fatigue properties of tissue

● Currently working on a parallel independent study to develop functional tissue engineered heart valve

● Research experimental studies and literature related to the field of cardiovascular mechanobiology

● Accepted into 2018-2019 Coulter Undergraduate Research Excellence (CURE)