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高級研發(fā)工程師-醫(yī)療器械

紐迪希亞貿(mào)易（上海）有限公司

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本科
02-23 發(fā)布

職位信息

職位名稱：高級研發(fā)工程師-醫(yī)療器械

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職位描述：Implement and complete medical device relevant projects, contribute professionally for project management and cost evolution. Ensure the products compliance with the legal and regulatory functions and end- user requirements. Take responsibility for the R&D and qualification of Medical Devices components development, including the user & design requirements integration, establishment of specifications, risk assessment and mitigation, ensuring the products are fit for the production technology within Wuxi or third parties.開展相關(guān)醫(yī)療器械產(chǎn)品的開發(fā)和改進(jìn)項目，為項目管理和成本控制做出專業(yè)性貢獻(xiàn)；確保產(chǎn)品符合法律法規(guī),性能指標(biāo)及客戶要求。負(fù)責(zé)醫(yī)療器械零部件開發(fā)和驗證工作，包括用戶需求的導(dǎo)入，產(chǎn)品性能參數(shù)標(biāo)準(zhǔn)的制定，項目全程風(fēng)險評估以及管控，保證合格零部件的批量生產(chǎn)。Project management項目管理1. Identify and explore opportunities and implement projects for cost evolution, or product quality improvement, ensure relevant project comply with high quality and efficiency.開發(fā)并主導(dǎo)完成成本控制、產(chǎn)品改進(jìn)等項目，確保項目按時有效地完成2. Coordinate cross-function team with good project management for big project implement, e.g.Design for automation manufacturing and sustainable development relevant long term project.協(xié)調(diào)跨部門之間的合作，主導(dǎo)大項目的開展，例如：公司層面的優(yōu)化設(shè)計直至自動化生產(chǎn)和可持續(xù)發(fā)展等一些長期性項目。Product design and component development醫(yī)療器械設(shè)計與零部件開發(fā)工作1. Good understanding of the relevant international and national (ISO, EN) standards related to the design and development of components, sub-assemblies and finished products for medical enteral applications. Principles of Usability Engineering standard and design for manufacturing should be understood and applied.較好地了解醫(yī)療行業(yè)零件和成品的相關(guān)設(shè)計的國內(nèi)國際ISO標(biāo)準(zhǔn)，熟悉并掌握與標(biāo)準(zhǔn)相關(guān)的產(chǎn)品測試要求。2. Based on the ISO standards or input and requirements from local and global marketing, manufacturing, legal, quality and sourcing department, generate ideas as to complete design of components and finished product.能夠根據(jù)標(biāo)準(zhǔn)要求，以及市場，法律法規(guī)，生產(chǎn)，質(zhì)量及采購等相關(guān)部門的輸入，完成現(xiàn)有零件及成品設(shè)計。3. Determine the user requirements based on the cooperation with Europe R&D center and relevant departments. Follow the project development progress and ensure user requirement to be aligned.與R&D總部及相關(guān)部門緊密協(xié)作，制定正確的用戶需求。定期檢查供應(yīng)商項目開發(fā)進(jìn)程，保證用戶需求的正確執(zhí)行。4. Participate and organize risk assessments and draft the test protocol, assess supplier test results and issue the deviations and actions. Finish the In-House test.參與并組織風(fēng)險評估活動，起草產(chǎn)品確認(rèn)所需的測試需求，評估供應(yīng)商測試結(jié)果，并提出偏差整改要求。負(fù)責(zé)完成In-House的測試項目。Education & working experience 學(xué)歷與工作經(jīng)驗要求：1.Master degree education or above, with majored in Engineering, the mechanical and polymer background preferred.碩士以上學(xué)歷, 工科背景，機(jī)械設(shè)計和高分子材料類專業(yè)優(yōu)先2.5+ years related the plastic injection molding and the Medical Devices. Experience in international company preferred.5年以上塑膠件注塑和醫(yī)療器械行業(yè)工作經(jīng)歷，有外資工作經(jīng)驗者優(yōu)先3.Capable to manage small or medium projects.有較好的項目管理經(jīng)驗Occupational qualifications職業(yè)資格要求：1.Be familiar with plastic materials injection process and plastic product automation assembly.具備殷實的塑料注塑成型工藝相關(guān)知識，和良好的零件設(shè)計、優(yōu)化技能2.Knowledge of the standard for quality system, e.g. ISO 13485. Be familiar with the ISO10993.了解一些標(biāo)準(zhǔn)質(zhì)量體系，如ISO13485；熟悉ISO10993或等同法規(guī)3.Proficient English communication skill (written and verbal)良好的英語聽、說、讀、寫能力4.Excellent MS office skills能夠熟練使用辦公軟件

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