職責(zé)描述：
Responsibilities:：
1)Report to the Manager of Design Department, responsible for the quality of design、quality of manufacturing;
匯報(bào)給設(shè)計(jì)經(jīng)理，負(fù)責(zé)產(chǎn)品設(shè)計(jì)、產(chǎn)品質(zhì)量、及產(chǎn)品生產(chǎn)質(zhì)量；
2)Study and research on benchmark products, definite competitive features for new product;
學(xué)習(xí)、研究樣機(jī)，為新產(chǎn)品制定競(jìng)爭(zhēng)力的特征；
3)Evaluate resources: supplier’s capability、man powers、equipments for test and production and any special related equipment, analyze cost and lead time of new products and components;
評(píng)估新產(chǎn)品相關(guān)的信息和能力：供應(yīng)商能力、人力資源、測(cè)試設(shè)備等，成本分析和開(kāi)發(fā)周期；
4)Designs and develops new medical products、medical components and packaging per the requirements for medical devices;
設(shè)計(jì)開(kāi)發(fā)和改進(jìn)新的醫(yī)療產(chǎn)品、醫(yī)療部件和相關(guān)包裝；
5)Create drawings、technical documentations based on Quality、Regulatory and procedure requirements;
根據(jù)質(zhì)量、法規(guī)和相關(guān)流程，創(chuàng)建圖紙、技術(shù)文檔；
6)Selection and testing of suitable materials of construction of the device.
為醫(yī)療產(chǎn)品選擇和測(cè)試合適的材料；
7)Check tolerance、strengthen (not limited) to decrease failure rate of realization of new product and components at design period;
設(shè)計(jì)初始階段完成相關(guān)尺寸鏈、強(qiáng)度和產(chǎn)品功能校核，減少產(chǎn)品和項(xiàng)目失效風(fēng)險(xiǎn)；
8)Create criteria for all functional testing on the primary stages of development;
為產(chǎn)品改良、設(shè)計(jì)創(chuàng)建產(chǎn)品測(cè)試要求、驗(yàn)收標(biāo)準(zhǔn)
9)Trace sample making、verification、validation、 tooling making、pilot run , to ensure deliver qualified components and products on time;
跟蹤樣品制作、驗(yàn)證、模具制作、小批量試制，確保按時(shí)發(fā)布合格的產(chǎn)品和部件；
10)Support on manufacturing volume run, solve the problems occurred in production line、create working instruction、develop fixtures for manufacturing, etc.;
支持生產(chǎn)部門(mén)批量生產(chǎn)，解決生產(chǎn)線發(fā)生的問(wèn)題、創(chuàng)建新產(chǎn)品組裝說(shuō)明書(shū)、制作和改進(jìn)生產(chǎn)相關(guān)治具及設(shè)備；
11)Works closely with Project Managers and Intercompany departments on project realization, from Concept Development through to Product Launch;
從新產(chǎn)品定義階段到批量生產(chǎn)的整個(gè)開(kāi)發(fā)過(guò)程，同項(xiàng)目部及相關(guān)部門(mén)密切合作，解決技術(shù)問(wèn)題，確保項(xiàng)目順利的進(jìn)行；
12)Cooperate with Patent Administrator to file patent applications；
同專(zhuān)利專(zhuān)員合作，提交所需相關(guān)，以取得相關(guān)專(zhuān)利權(quán)。
13)Other tasks assigned by Managers.
管理人員分配的其它任務(wù)。
任職要求：Requirements（要求）:
1)BS degree or junior, major in Mechanical Engineering, or related equivalent. 3~8 years working experience in medical field ;
本科或大專(zhuān)，機(jī)械工程及相關(guān)專(zhuān)業(yè)；3-8年醫(yī)療器械相關(guān)工作經(jīng)驗(yàn)；
2)Creative individual with proven problem solving skills is a MUST;
必須具有豐富的解決問(wèn)題的能力，具備創(chuàng)新性；
3)Good understanding of precision plastic molded component design and assembly methods；
豐富的塑料模具成型經(jīng)驗(yàn)及塑料產(chǎn)品設(shè)計(jì)、裝配經(jīng)驗(yàn)和知識(shí)；
4)Good understanding of polymer science, materials selection and testing methods；
全面的了解聚合物科技知識(shí)，及材料選擇和測(cè)試方法；
5)Familiar with design and development process；
熟知設(shè)計(jì)和開(kāi)發(fā)流程；
6)Able to complete tasks independently in a logical, analytical manner and document results；
能夠合理地獨(dú)立完成分配的任務(wù)，通過(guò)系統(tǒng)性考量、分析和記錄結(jié)果；
7)Must be proficient in 3D CAD software ( Solid Works and Pro Engineer preferred);
必須熟練應(yīng)用3維設(shè)計(jì)軟件（最好是Solid Works 和 PROE）;
Must have sound understanding of the Quality Management system as per the requirements of ISO 13485, Medical Device Directive, Chinese regulations for medical devices. The requirements of FDA CFR 21 Part 820 and J-PAL a plus.
必須了解醫(yī)療品質(zhì)體系ISO13485相關(guān)要求、醫(yī)療器械設(shè)備指令、中國(guó)相關(guān)醫(yī)療器械相關(guān)法規(guī)。 最好了解FDA CFR 21分章820和J-PAL.
8)Fluent English and Chinese speaking, reading and written skills is preferred.
最好有流利的英語(yǔ)和漢語(yǔ)表達(dá)能力、讀寫(xiě)能力。

蘇州林華醫(yī)療器械有限公司成立于1996年，位于蘇州工業(yè)園區(qū)，座落于美麗的陽(yáng)澄湖畔，工廠占地面積8萬(wàn)平米，其中十萬(wàn)級(jí)凈化車(chē)間有2萬(wàn)平方米，擁有員工千余人。距離上海虹橋機(jī)場(chǎng)只需40分鐘車(chē)程，距離蘇州園區(qū)城鐵站僅5分鐘車(chē)程。
2008年林華醫(yī)療創(chuàng)新發(fā)明了防堵管留置針，成為此領(lǐng)域的領(lǐng)軍人。
在防堵管留置針領(lǐng)域，林華持續(xù)創(chuàng)新，采用美國(guó)創(chuàng)新技術(shù)支撐中國(guó)“防堵管”留置針領(lǐng)導(dǎo)品牌 ；并將國(guó)際先進(jìn)理念與中國(guó)臨床實(shí)踐相結(jié)合，在國(guó)內(nèi)首先成功投入臨床推廣使用。
林華醫(yī)療多年來(lái)與國(guó)內(nèi)大型醫(yī)院、中華護(hù)理學(xué)會(huì)、美國(guó)邁阿密大學(xué)等長(zhǎng)期合作，致力于為臨床提供優(yōu)質(zhì)的產(chǎn)品、先進(jìn)的護(hù)理理念與國(guó)際化學(xué)術(shù)支持。