丰富的医疗器械研发及支持相关经历,拥有多个产品的研发设计经验,掌握医疗器械设计中的测试,临床前评价如动物实验,熟悉医疗器械各种法规,能够处理相关过程中关键问题。
美敦力公司
View- Website:
- medtronic.com
- Employees:
- 75896
-
Senior R&D Bioanalyst美敦力公司 Mar 2015 - Present◆ Sr.bioanalyst ◆ microbiologist microbial analysis of medical devices,cleaning and sterilization validation of reusable medical devices,autoclaving、Radiation Sterilization and inhibition study. ◆ Sr. biological evaluation analyst lead and execute bioanalytical method development/validation and perform sample analysis following GLP standards and protocol /SOP according to ISO10993/GB16886 in R&D,establish biocompatibility database. -
R&D Engineer微创医疗 Mar 2012 - Mar 2015中国 上海R&D/Clinical Medicine R&D engineer R&D engineer of neurovascular interventional medical devices. ● Veterinary Engineer:Drawing up the entire Neurotech preclinical animal experimental program.and finished two programs animal study. Completing biological evaluation in animal model, verifying catheter compatibility and product validity. Assisting doctor to complete the experiment and pathologic evaluation. ● Liquid embolic material: The material we developing is for the treatment of intracranial aneurysms. I have been solved: a) developing under DSA. b) Physical property test such as pushability in catheter, stickiness, diffusibility, adherence.....with DFMEA and go through clinical needs. c) Biological testing cytotoxicity, hemolysis and toxicokinetics , especially neurotoxicity(OCED 426) established a variety of testing methods. ● Embolectomy:Improve mold design material and soldering tip head. Enhance their ability to take thrombus, making the stent less harmful to the artery. Testing retracement and wire’s tip plasticity ● In charge of Microbiology Lab Established microbiological testing center, including initial equipment purchase, PQ validation about Air-conditioning system, SOP and related documents in accordance with the GMP.
Frequently Asked Questions about 张玉成
What company does 张玉成 work for?
张玉成 works for 美敦力公司
What is 张玉成's role at the current company?
张玉成's current role is Senior R&D bioanalyst.
What schools did 张玉成 attend?
张玉成 attended 上海交通大学.
Who are 张玉成's colleagues?
张玉成's colleagues are Johnpaul Castillo, Gaming Monster, Mike Knott, Alexandria Lizza, Mba, Matluba Irgasheva, Dorfman Shane, Ryan Collins.
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