Melinda Tiao

- Design and develop sustainable medical devices and accessories for sports medicine and orthopedic surgeries, from design concept to commercialization release of medical devices - Comply with appropriate regulatory agencies (i.e. GMP, ISO, FDA, etc.) and associated quality systems - Organize projects, document procedures and results, and maintain Design History Files (DHF)/Design Master Records (DMR) - Design, model, and draw in Solidworks to create prototypes for verification and validation (V&V) - Perform and document V&V protocols to test product design, quality, and function - Assist in training personnel in design control processes (design inputs/outputs, risk assessment and management, V&V, etc.) associated with design and development of medical devices and accessories - Correspond with and approve appropriate suppliers for product manufacturing (DMFs, submit POs, ensure proper compliance, etc.) - Review and aid in the submission of 510(k)s to the FDA - Assist in investigation, documentation, and resolution of product complaints - Perform and document incoming manufacturing and quality inspections of products before release - Continually optimize manufacturing procedures to produce cost effective, high quality medical devices - Complete Document Change Orders (DCO)/Engineering Change Orders (ECO) and control processes and procedures - Attend medical conferences/conventions - Market mission and products (GreenRepair Podcast)

- Complete, review, & revise completed batch records, logbooks, & SOPs in accordance with cGMP standards & compliant with written procedure - Assist, monitor, & perform tasks in all areas of production, including bioreactor operations, manufacturing level maintenance, validation of processes, & quality control according to FDA & xGMP standards - Optimize, trend, & report manufacturing process operational parameters during manufacturing campaigns

- Helped 200+ youths, 0-8 years, develop technical & communication skills - Utilized leadership skills in order to manage 10-15 participants per session - Collaborated with other coaches to improve efficiency and effectiveness of curriculum - Supervised and trained new hires for a fast paced & constructive learning environment

Dr. Jun Xia - UB Biomedical Engineering Department - Assisted clinical imaging study by obtaining participant data/consent & performed qualitative analysis of images utilizing Python/MATLAB - Utilized participant feedback to aid in the design of a more ergonomic & accurate imaging setup - Designed, modeled, & created 3D printed components for optical imaging/setup utilizing Fusion 360 - Invented & fabricated, from conception, novel system for breast imaging & tested for functionality - Designed & built water tanks utilizing Fusion 360 and machine tools (ie. table saw, milling machine, band saw, and drill) - Aided in writing, drawings, & publication of research papers

- Introduced C-based programming language to 10-15 elementary & middle school students per class - Instructed fundamental engineering principles & concepts through hands-on, interactive projects

Applied Technology Laboratory for Advanced Surgery (ATLAS) - Oversaw completion of spatial analysis surveys for study & answered participants questions - Assisted current study by performing literary research - Obtained, reviewed, and analyzed study documents & participant data - Compiled research data for analysis utilizing RedCap - Delivered findings in an organized fashion in order to accurately report metrics and results

CLIMB UP Research Experiences Dr. Ciprian N. Ionita - UB Biomedical Engineering Department - Participated in an animal study to test the efficacy & effectiveness of a treatment for aneurysms - Assisted with preparation of ~20 samples for analysis utilizing scanning electron microscopy - Presented findings to colleagues & other researchers - Gained laboratory experience with preparing slides/samples, cell & tissue cultures, protein characterization, animal handling & euthanasia, etc.

- Created and executed camp curriculums for groups of 20-30 participants - Organized sessions to improve efficiency and effectiveness of curriculum - Helped youths 4-13 years develop technical & communication skills - Led groups of 10-13 children through drills & exercises - Collaborated with other coaches to improve efficiency & effectiveness of program

concentration in mechanical & electrical engineering

Study Abroad: UB Italy - Classics in the Mediterranean - Adapted to an unfamiliar environment, utilizing communication & organization skills to navigate - Managed finances in varying currencies