Hsin-I Lin Email and Phone Number

•. Currently lead five medical device projects; two are in MP, one is in pre-production phase and the other two are in sample production. Three products have obtained CE and FDA approvals.•. Cooperate with project members (+10 people/ project) for HW/FW/SW/Mechanical design, troubleshooting, product verification and validation.• Communicate with clients directly for schedule, R&D issues, specification, SOP, IQC, and FQC.• Perform risk analysis using D-FMEA during product’s life cycle; release and maintain technical documents of medical devices for FDA, CE and TFDA (DHF, DMR, TCF and software Verification and Validation)• Built ISO13485, ISO14971 and IEC62366 system and combine current ISO9001 quality system.• Had business trip in USA for visiting client and setting up rework station.• Educate team members (R&D, QS) for products and risk management by hosting seminars and giving speech.

•Currently have two team members (Maximum is 4).•Recruit and screen potential engineers for firmware department and design interview procedure, training plan.•Provide solution and resources, discuss with engineers for troubleshooting and schedule; guide engineers’ format of presentation, project and working report.•Assign projects based on employee’s personality and goals; evaluate the performance and salary. •Provide outside training class for their needs.

•Established firmware of medical devices, which are the reader of endoscopy and blood analyzer, using USB controller Cypress FX2LP and motor controller tms320f28030.•Developed firmware of scanner for more than 10 projects using ASIC designed by Avision, Zoren S5, Thread X, CCD/CIS and ADC to control scanner motor behavior, external mass storage device, calibration, image progressing.•Issued engineering changes for function changes or bug closing.•Worked closely with hardware, software, mechanical engineers for function implement and estimated the schedule with PL, PM. •Cooperated and addressed problems with client and went to China and Japan for business trips for more than 15 times.•Earned top 3 of best performance firmware engineer on year 2009 and 2010.•Processed products selling over 50,000 units US$7,500,000) from year 2008 through 2011.

• FW programming for medical device. •. Medical device project management.

Grading homework

Biomedical Engineering