Chen Hao

Chen Hao Email and Phone Number

Biomedical Engineer, Quality Management @ iRay Imaging LLC
Solon, OH, US
Chen Hao's Location
Indianapolis, Indiana, United States, United States
Chen Hao's Contact Details

Chen Hao personal email

n/a
About Chen Hao

Certified Quality Engineer with 5 years of experience in medical device industry, including development, manufacturing, and post market surveillance. Industrial understanding of 21 CFR 820, ISO13485 & ISO14971. I have extensive experience in design control, design change, non-conforming products, risk management, root cause analysis, and problem solving. Certified GDTP - 2009 senior level (ASME Y14.5 – 2009).

Chen Hao's Current Company Details
iRay Imaging LLC

Iray Imaging Llc

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Biomedical Engineer, Quality Management
Solon, OH, US
Website:
iraygroup.com
Employees:
123
Chen Hao Work Experience Details
  • Iray Imaging Llc
    Biomedical Engineer, Quality Management
    Iray Imaging Llc
    Solon, Oh, Us
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  • Iray Imaging Llc
    Biomedical Engineer, Quality Management
    Iray Imaging Llc May 2024 - Present
    Solon, Ohio, United States
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  • 3Dmed Diagnostics
    Senior Quality Assurance Engineer
    3Dmed Diagnostics Jan 2022 - May 2024
    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.
  • Beckman Coulter Diagnostics
    Quality Engineer Ii
    Beckman Coulter Diagnostics Jun 2020 - Dec 2021
    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.
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  • Zimmer Biomet
    Quality Engineer
    Zimmer Biomet Jun 2017 - Jun 2020
    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.
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  • Zimmer Biomet
    Product Development Engineer
    Zimmer Biomet Jul 2016 - Jun 2017
    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.
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  • Purdue School Of Engineering And Technology, Iupui
    Research Assisatnt At Advanced Printed Electronics Lab
    Purdue School Of Engineering And Technology, Iupui Sep 2015 - Jul 2016
    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)
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  • Purdue School Of Engineering And Technology, Iupui
    Research Assistant At Vascular Mechanobiology Lab
    Purdue School Of Engineering And Technology, Iupui May 2015 - Aug 2015
    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)
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  • Tianjin University
    Research Assistant
    Tianjin University Jun 2013 - Sep 2013
    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)
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  • Tianjin University
    Research Assistant
    Tianjin University Sep 2011 - Sep 2012
    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)
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Chen Hao Skills

Matlab Microsoft Office Autocad Sas Patience Time Management Public Speaking Solidworks Imagej Photoshop Ansys Cell Culture Protocol Development E Learning Uv Lithography Teamwork Fast Paced Self Motivated Root Cause Analysis Iso 13485 Design Failure Mode And Effect Analysis Technical Writing 21 Cfr 803 21 Cfr 820 Comsol Medical Device Reporting Post Market Surveillance Iso 14971 Design Control Geometric Dimensioning And Tolerancing Gauge R&r Minitab Statistical Process Control Certified Quality Engineer

Chen Hao Education Details

Frequently Asked Questions about Chen Hao

What company does Chen Hao work for?

Chen Hao works for Iray Imaging Llc

What is Chen Hao's role at the current company?

Chen Hao's current role is Biomedical Engineer, Quality Management.

What is Chen Hao's email address?

Chen Hao's email address is ch****@****met.com

What schools did Chen Hao attend?

Chen Hao attended Indiana University-Purdue University At Indianapolis, Tianjin University.

What are some of Chen Hao's interests?

Chen Hao has interest in Harmonica, Guitar, Table Tennis, Soccer, Education, Photography, Science And Technology, Drawing, Arts And Culture.

What skills is Chen Hao known for?

Chen Hao has skills like Matlab, Microsoft Office, Autocad, Sas, Patience, Time Management, Public Speaking, Solidworks, Imagej, Photoshop, Ansys, Cell Culture.

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