Chen Hao Email & Phone Number

Solon, Oh, Us

Solon, Ohio, United States

Shanghai

3DMed Diagnostics, Shanghai, ChinaResponsibilities：• Overseen instrument life-cycle quality activities from development, manufacturing to PMS.• Responsible for internal and external audits.• Guided and trained colleagues to produce compliance and valid results.Achievements：• Prepared and passed on-site audits for product registration, ISO 13485, MDSAP, NRTL, and MAH, etc. Audited MAH contract manufacturer for 3DMed.• Overseen 4 class II instrument production lines from requirements through reviews to V&V and completed NMPA registration. • Took the initiative and established templates & processes to improve efficiency, such as VBA automation tool, MTBF review panel, test protocol/report template, tolerance stack-up, and test methods.• Led a cross-functional team to verify, implement, and monitor design changes(including fixture validation) for over 50 problems.• Studied and communicated the need for IEC 62304, cybersecurity, reliability, etc.

Chaska, Minnesota, United States

Responsibilities：• Monitoring, investigating, and dealing with day to day product quality issues. • Risk assessment and risk file update as a risk specialist. Achievements：• Trained development team, manufacturing team, and production team with QMS, NC disposition, equipment PM, design changes, and lead daily MRB meetings.• Reduced Defect per Unit (DPU) from 0.9 to 0.6.• Took extra responsibilities when the team lacked resources and prevented the production from line down.

Warsaw In

• Currently working in Post Market Surveillance Department, my responsibility is complaint investigation.• Performed root cause analysis on medical device complaints, based on reviewing device history records, certificate of conformance from supplier, complaint search, supplier agreement, etc.• Performed risk assessment by reviewing risk management file.• Wrote technical report for complainants and communicated with sales representative with phone calls and emails.• Determined if a complaint should be reported to FDA, and European Competent Authorities, based information from sales representative, surgical techniques, legal documents from patients' lawyer, operative notes, X-ray and third-party X-ray review.• Helped teammate determine if a event is serious injury/malfunction based on 21 CFR 803 and Medical Device Reporting for Manufacturers Guidance for Industry.

Warsaw, In

• Reviewed Design History Files (DHFs), surgical techniques, etc. to comprehensive understand implants systems (Total/Partial Knee Arthroplasty).• Performed risk management analysis to identify DFMEA Gaps.• Documented Design Control Tractability Matrix(DCTM) and Gap Tracker to identify Gaps in DHFs and propose Gap Closure.• Applied DIP/DIR, FRA and CPS to close Gaps.• Prioritized projects and managed time in a high pace environment to complete works ahead of time.

Indianapolis, Indiana Area

• Fabricated linear and spiral microfluidics channels (smaller than 1cm * 2cm * 1cm) for cells’ microfluidics tests (UV-lithography)• Simulated microfluidics in linear microfluidics channels for a better design (COMSOL)• Tested linear and spiral microfluidics channels with human breast cancer cells (MDA-MB-231) and polymer beads for exploring the separation efficacy of microfluidics channels (Self-Motivated)• Designed linear and spiral microfluidics channels for fabrication and simulation (AutoCAD)• Trained other students who need to use UV-lithography for other applications (Notice of Details)• Documented plans, procedures, results and reports for troubleshooting and review (Documentation)

Indianapolis, Indiana Area

• Validated a new device for uniaxial cell cyclic stretch (Testing)• Cultured cells in silicone membrane successfully for preparation of cyclic stretch (Trouble Shooting)• Transformed qualitative data (cell images) to quantitative data (numbers) to analyze the differences (Matlab)• Cultured Bovine Aorta Endothelial Cells and Mouse Embryonic Fibroblasts for preparation of experiment (Cell Culture)• Reduced the cost of reagent by 50% (Protocol improvement)

中国 天津

I was working in a project at Pharmaceutics Lab of Tianjin University for the whole summer. the project is about to improve the bioavalibility of Nimodipine. • Presented project results to project committee. (Communication skills)• Rotated with team members to make sure everything went on time. (Time management)• Took blood from rabbits’ ear. Collected data by Ultraviolet–Visible Colorimeter and recorded every step. (Animal care experience)

中国 天津

I worked in Tradition Chinese Medicine Lab of Tianjin University in my second year of undergrad.Basically, I was learning basic lab knowledge, the way to do research and helping prepare samples.• Searched for information & refined it from literature, which was summarized and presented to teammates. (Communication skills)• Collected data with weight from Analytical balance & analyzed by Matlab. (Matlab)

Master'S Degree, Biomedical Engineering

Activities and Societies: Program Coordinator in Biomedical Engineering Graduation Student Association(BMEGSA)I was addicted in computer.

Bachelor Of Engineering (Be), Pharmaceutical Engineering

Activities and Societies: International Society of Pharmaceutical Engineering (ISPE)