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Definition of Reputation Credits
Daniel Yu
Vice President
Taiwan
- Experienced Vice President with a demonstrated history of working in design, development and manufacturing of medical devices in the biological industry. (11 years' experience in Somnics, Inc.)
- Skilled in design and development of innovative bio-technologies, including microfluidic, wound care, health care and surgical equipment. (7 years' experience in ITRI)
- Strong professional with a Ph.D. focused in the research of organic optoelectronic tweezers (OET) and opto-electrowetting (OEW) for control cell and droplet movement in the microfluidic system. (6 years' experience in NCTU and NTHU)
工作經歷
Vice President • Somnics, Inc.
一月 2011 - Present
1. R&D Director:
- Lead the design and development of Negative pressure sleep therapy system and Sleep monitor (ECG, PPG, Air flow)
- Lead the project team for interdepartmental communication among R&D, PO and QARA departments
- Coordinate R&D team to generate technical documents for TFDA, CFDA, CE and FDA certificates
- Support clinical study in sleep centers
- Support patent management
2. Production operations Director:
- Execute planned production and built-to-order production
- Manage and maintain the operation of GMP Factory in Taiwan
- FAE and RMA support
- Support new product introduction
- Support DMR documents and maintain DHF
- OEM projects: EVT build of COVID-19 nucleic acid test kit, the assembly and test of the licensed ventilator prototype
- Government project: Carbon footprint certificate of the refurbished product
3. Management representative (China):
- Lead technology transfer and maintain quality system in Sichuan
- Complete the process of defining medical device classifications
- Complete on-site quality system audit
- Complete the registration document review process
收回
Engineer • 工研院
十一月 2003 - 十二月 2010
I am engaged in the development of the innovative biomedical technologies in ITRI, including:
1. Microfluidic system:
- PCR chip system: integrate hardware and software to build the rapid thermal cycle platform for completing PCR process in 30 mins
- Cell chip system: develop the constant temperature and machine vision system for cell culture
- DNA chip system: build the platform to amplify DNA with a rapid PCR process and detect its electrical signal
- DEP chip system: develop a platform which can generate different frequency waves to control the movement of cells in the electrodes on the chip
2. Wound care medical device:
- Negative pressure wound therapy (NPWT): contribute on design concept, patent filing and prototype development
3. Health care medical device:
- Intermittent pneumatic compression (IPC): contribute on design concept and prototype development and release related technical documents in the design phase
- Automated tablet dispensing system: contribute on GUI design and implementation to dispense different tablets in different boxes
4. Surgery equipment:
- Electro-coagulation system: contribute on GUI design and implementation, PID temperature control of the high frequency equipment by PLC
6. Electromechanical integration:
- Automatic instrument control by LabVIEW: (1) DAQ, IMAQ, PDA, Touch Panel, and PXI. (2) Design pattern (Product/Consumer, State Machine, Queued Message Handler)
- Microcontroller firmware development: Microchip and holtek
收回
學歷
2007 - 2013
National Chiao Tung University
Electrophysics
2001 - 2002
National Chiao Tung University
Electrophysics
資格認證
MMOT跨領域科技管理研習班
財團法人磐安智慧財產教育基金會
發照日期 十月 2014 · 永久有效
WBSA初階商務企劃員
World Business Strategist Association
TWC000666
發照日期 三月 2008 · 永久有效
技能
User Experience
- User testing
- Web usability
Product
- Competitor analysis
- Business research
Language
- Chinese
- English
Daniel Yu
Vice President
Taiwan
- Experienced Vice President with a demonstrated history of working in design, development and manufacturing of medical devices in the biological industry. (11 years' experience in Somnics, Inc.)
- Skilled in design and development of innovative bio-technologies, including microfluidic, wound care, health care and surgical equipment. (7 years' experience in ITRI)
- Strong professional with a Ph.D. focused in the research of organic optoelectronic tweezers (OET) and opto-electrowetting (OEW) for control cell and droplet movement in the microfluidic system. (6 years' experience in NCTU and NTHU)
工作經歷
Vice President • Somnics, Inc.
一月 2011 - Present
1. R&D Director:
- Lead the design and development of Negative pressure sleep therapy system and Sleep monitor (ECG, PPG, Air flow)
- Lead the project team for interdepartmental communication among R&D, PO and QARA departments
- Coordinate R&D team to generate technical documents for TFDA, CFDA, CE and FDA certificates
- Support clinical study in sleep centers
- Support patent management
2. Production operations Director:
- Execute planned production and built-to-order production
- Manage and maintain the operation of GMP Factory in Taiwan
- FAE and RMA support
- Support new product introduction
- Support DMR documents and maintain DHF
- OEM projects: EVT build of COVID-19 nucleic acid test kit, the assembly and test of the licensed ventilator prototype
- Government project: Carbon footprint certificate of the refurbished product
3. Management representative (China):
- Lead technology transfer and maintain quality system in Sichuan
- Complete the process of defining medical device classifications
- Complete on-site quality system audit
- Complete the registration document review process
收回
Engineer • 工研院
十一月 2003 - 十二月 2010
I am engaged in the development of the innovative biomedical technologies in ITRI, including:
1. Microfluidic system:
- PCR chip system: integrate hardware and software to build the rapid thermal cycle platform for completing PCR process in 30 mins
- Cell chip system: develop the constant temperature and machine vision system for cell culture
- DNA chip system: build the platform to amplify DNA with a rapid PCR process and detect its electrical signal
- DEP chip system: develop a platform which can generate different frequency waves to control the movement of cells in the electrodes on the chip
2. Wound care medical device:
- Negative pressure wound therapy (NPWT): contribute on design concept, patent filing and prototype development
3. Health care medical device:
- Intermittent pneumatic compression (IPC): contribute on design concept and prototype development and release related technical documents in the design phase
- Automated tablet dispensing system: contribute on GUI design and implementation to dispense different tablets in different boxes
4. Surgery equipment:
- Electro-coagulation system: contribute on GUI design and implementation, PID temperature control of the high frequency equipment by PLC
6. Electromechanical integration:
- Automatic instrument control by LabVIEW: (1) DAQ, IMAQ, PDA, Touch Panel, and PXI. (2) Design pattern (Product/Consumer, State Machine, Queued Message Handler)
- Microcontroller firmware development: Microchip and holtek
收回
學歷
2007 - 2013
National Chiao Tung University
Electrophysics
2001 - 2002
National Chiao Tung University
Electrophysics
資格認證
MMOT跨領域科技管理研習班
財團法人磐安智慧財產教育基金會
發照日期 十月 2014 · 永久有效
WBSA初階商務企劃員
World Business Strategist Association
TWC000666
發照日期 三月 2008 · 永久有效
技能
User Experience
- User testing
- Web usability
Product
- Competitor analysis
- Business research
Language
- Chinese
- English