firstname.lastname@example.org 580-***-**** Arlington, TX 76013 (Permanent Resident)
Experienced Combination Product and Medical Device Engineer
Project Management Design & Quality Controls Risk Management Statistical Analysis
Design V&V Process Validation DHF writing Usability Engineers
EXPERIENCES AND ACHIEVEMENTS
NOVARTIS, Fort Worth, TX 2016- Present
•Investigate bench performances of ophthalmic procedures from a clinical and user needs perspective for several projects: Intraocular Lens (IOL) delivery system/corneal incision and Vitrectomy device.
•Communicate effectively novel findings with design engineers, quality engineers, regulatory affairs and marketing team, write DHF reports, publish results and identify opportunities for innovation.
•Contribute technical supports for device design tolerance stack analysis, verification and validation, risk management and design transfer as a core team member, influence peers cross functionally and mentor junior engineers within department.
•Generate user-centered nozzle tip used in IOL delivery system through analysis of pre-clinical data and marketing inputs and communication with clinical manger as well as computer modeling.
•Guide junior engineers for risk analysis of pre-loaded IOL delivery system with dFMEA study.
•Initialize and manage project of computer simulation virtual study for IOL delivery system to guide directions for design and clinical teams enabling precise delivery of IOL into capsular bag in patients.
•Develop scope of project (SOP) and timelines, allocate resources and resolve potential project issues for functional managers/directors.
•Organize and lead team meetings to monitor and communicate work progress according to plan.
•Collaborate proactively with clinical manager to perform pre-clinical study to ensure that Alcon AutonoMe automated pre-loaded IOL delivery system meets surgeons’ requirements and is in accordance with FDA and EU medical device regulations.
•Accelerate design change process for new product development and on market maintenance of IOL delivery system to significantly reduce incision size enlargement of cornel during procedure.
•Perform Moldflow analysis, mold process design of experiments (DOE) study and capability analysis for high quality of thin wall nozzle tip manufacture with third party venders.
•Work actively with regulatory affairs to support quality and marketing teams about Alcon probe device performance by planning and executing bench testing, data analysis and computer modeling.
•Provide recommendations to improve safety and effectivity of next generation probe during surgical procedure and assist CNC shop to build prototype of vitreous-cutter probe. Succeed in increasing flow rates of vitreous flow and balanced salt solution while reducing traction forces on the retina.
ABBVIE, Chicago, IL 2015 – 2016
•Supported auto-injector development activities including technical feasibility, tolerance stack analysis, V&V study, risk management, human factors assessments and DHF writing.
•Ensured all design functions of combination medical devices comply with FDA and EU regulations for several ergonomic devices: auto-injector pens, peristaltic pump and disposable drug reservoir.
•Utilized analytical and statistical techniques throughout projects to make risk based decisions.
•Developed and validated test methods pertaining to container closure integrity (CCI) test, biocompatibility test (E&L) and device function test for ergonomic combination products.
•Performed dFMEA study of auto-injection pens to diagnose risk, investigate root cause and mitigate issue of delay injection process of auto-injection pens for high concentration Humira.
•Conducted human factors usability and acceptability assessments to demonstrate auto-injector pen for Humira to be safely and effectively used by patients and HCPs.
•Collaborated actively with team members to investigate manufacturing process analysis of plastic parts of medical devices by Moldflow analysis & injection molding DOE study.
•Guided operators for process validation of medical device ultrasonic assembly line automation including installation and operation qualifications as well as welding strength analysis.
•Identified and mitigated root cause of failure of peristaltic pump via DOE studies and implemented continuous improvement of pump assembly to specifications.
•Evaluated and improved dip tube design in next generation disposable drug reservoir (DDR) through CFD simulation, prototype building and lab testing.
University of Pittsburgh etc. 2011-2015
•Led a research team of several design professionals to support engineers and scientists from department and hospital through conceptual design to product completion.
•Obtained FDA standard, guidance, regulation trainings for medical devices & combination products.
•Developed CAE models of medical treatment & combination products performance analysis and performed lab testing and statistical analysis for hospital and pharmaceutical company.
•Collaborated actively with biologically inspired engineers in Harvard University to support design and improvement of novel dynamic biomolecule detection and separation microfluidic device for protein purification and published results at Nature Chemistry.
•Planned, designed and validated implantable ocular drug delivery device driven by micropump for age-related macular degeneration (AMD).
• DFSS, DFM/A, DOE, FMEA, GD&T, SPC, Design Control, ICH, Quality Control, FDA & EU regulations and ISO standards.
• CAD packages: Solidworks, Pro-E, CREO, Spaceclaim and Windchill;
CAE packages: Ansys, Mechanical, LS-Dyna, FLUENT, Abaqus, Moldflow, Matlab and Minitab.
• Programming languages: Fortran, C, C++, Python and shell scripting.
Graduate degree, Mechanical Engineering, University of Kansas, 2011