Medical Device Mechanical Engineer

TIFFANY CHIN YU

**** ***** ********* *******, ** 29631 – ****@*.*******.*** – 864-***-****

EDUCATION

Master of Science in Bioengineering– Clemson University – Clemson, SC Anticipated Graduation: Aug 2019 Bioelectrical Concentration GPA: 4.00/4.00

Thesis: Microfabricated Substrate to Achieve In Vivo-Like Cardiomyocyte Morphology and Electrical Propagation in Neonatal Cell Culture

Bachelor of Science in Bioengineering – Clemson University – Clemson, SC Graduation: May 2017 Biomaterials Concentration GPA: 3.76/4.00

QUALIFICATION HIGHLIGHTS

Medical Device Design Verification and Validation Testing Design Controls SolidWorks CAD Modeling FDA and ISO Compliance Communication Cross-Functional Teamwork Prototype Development and Evaluation Problem Solving Medical Clinical / Regulatory Pathways Minitab Statistical Analysis Design History Files Design of Experiment Clinician / Customer Interfacing Technical Writing RELATED EXPERIENCE

Bioengineering Graduate Researcher August 2017 – present Bioengineering Department – Biophotonics Lab – Clemson University o Determine optimal silicon substrate parameters for cardiomyocyte morphology and functionality o Use atomic force microscopy (AFM) to measure and analyze substrate microtopography o Fabricate metal and plastic machine prototypes for research use with SolidWorks 3D CAD o Study cellular cardiac electrophysiology and effects of cellular morphology changes on propagation o Communicate research work and ideas in weekly group meetings Graduate Grading Assistant for Engineering Graphics and Machine Design August 2017 – present General Engineering Department – Clemson University o Evaluate over 100 undergraduate engineering students each semester o Guide new grading assistants with grading process o Analyze student submissions of parts, assemblies, finite element analysis (FEA), and assembly animations o Provide insightful feedback to students on weekly SolidWorks assignments and projects o Administer Certified SolidWorks Associate (CSWA) exams to students each semester Preclinical Research and Development Intern June 2018 – August 2018 Cresilon, Inc. – Brooklyn, NY

o Collaborated with other departments, such as process development, research and development, and quality assurance

o Designed test fixture for observing mechanical properties of hemostatic gel, creating detailed and standardized test protocol

o Performed hands-on troubleshooting of in vitro assay design o Translated in vivo observations into in vitro assay o Assisted in porcine in vivo animal studies to evaluate medical device performance o Conducted data analysis on in vivo studies and wrote correlating summary reports o Devised all prototype designs and assemblies in SolidWorks and 3D-printed functional prototypes using stereolithography methods

o Exercised Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) guidelines o Worked in line with FDA 21 CFR Part 820 and ISO 13485 Quality Management System o Maintained knowledge of and evaluated competitive hemostatic products in vivo o Presented work to entire company biweekly updating project completion and goals o Writing a manuscript for publication of medical device competitor analysis for a surgical journal Graduate Regulatory and Clinical Affairs Project January 2018 – May 2018 Bioengineering Department – Clemson University

o Formulated a formal clinical protocol for FDA submission for a medical device o Included study design, endpoints, and enrollment, as well procedures, schedule, and safety assessments o Created informed consent form and clinical budget for medical device Graduate Bioinstrumentation Design Project August 2017 – December 2017 Bioengineering Department – Clemson University

o Constructed an electrocardiogram (ECG) hardware filtering circuit o Developed a LabVIEW program for data acquisition (DAQ) and signal processing of ECG o Utilized electrical instrumentation such as oscilloscopes, sensors, and analog data acquisition Bioengineering Medical Device Design Project August 2016 – May 2017 Bioengineering Department – Clemson University

o Worked in a cross-functional team to develop a Class II medical device prototype o Designed a novel electromechanical device to improve the pediatric intensive care units through partnership with clinicians in the Greenville Health System (GHS)

o Interacted with clinical specialists to incorporate customer feedback into design updates, bringing prototypes and designs to clinicians to translate engineering into clinical terms as well as integrate physician suggestions into engineering design inputs

o Created both a physical and electronic Design History File (DHF) for thorough documentation of design process o Identified risk parameters with DFMEA and MAUDE report analyses and traceability matrices o Planned and implemented verification and validation testing o Ensured FDA and ISO regulatory compliance and reimbursement o Presented all work in biweekly oral presentations and written reports o Conducted regular meetings to communicate novel work and receive feedback o Designed SolidWorks parts for integration into the medical device development Undergraduate Bioinstrumentation Design Project August 2016 – December 2016 Bioengineering Department – Clemson University

o Created MATLAB program for voice restoration of total laryngectomy patients o Constructed graphical user interface (GUI) for ease of use for patients Bioengineering Undergraduate Researcher August 2015 – May 2017 Bioengineering Department – Systems Mechanobiology and Biophotonics Lab – Clemson University o Fabricated PDMS silicon-based cell culture substrate o Cultured and aligned live cells on substrates for dynamic microscopic observation o Analyzed cell imaging data for sarcomeric addition and complied the extracted images into interpretable videos o Designed and microfabricated microstamping mold for studying in vivo-like heart cell-cell interaction with Autodesk Inventor 3D CAD

Undergraduate Teaching Assistant for Engineering Graphics and Machine Design January 2014 – December 2014 General Engineering Department – Clemson University o Tutored and participated in weekly class sessions o Graded in-class assignments

o Supplied weekly tutoring sessions to aid students with out-of-class assignments and projects o Proctored Certified SolidWorks Associate (CSWA) exams to students each semester ACTIVITIES AND INVOLVEMENT

BMES (Biomedical Engineering Society) Fall 2016 – present Alpha Eta Mu Beta Biomedical Engineering Honor Society Spring 2017– present Clemson Bioengineering Society - Treasurer Fall 2017 – present Tau Beta Pi Engineering Honor Society Spring 2016 – Spring 2017 Engineering World Health club (Secretary 2016) Spring 2016 – Spring 2017 LEADERSHIP EXPERIENCE

Treasurer – Graduate Clemson Bioengineering Society May 2018 – present o Maintain financial budget of $5000 for society, collaborating with other board members o Track finances for Clemson Bioengineering Department for hosting Society for Biomaterials (SFB) conference o Collect and document all membership fee payments Secretary – Engineering World Health, Clemson University Chapter August 2016 – May 2017 o Organized and participated in volunteer and outreach activities o Prepared and discussed meeting topics with executive board o Coordinated communication between executive board and members via email and social media

Contact this candidate