苏州招聘

职位描述：responsible for the Medical Devices designing. Ensure the products compliance with the function, legal and user requirements. Provide the qualified documentations. 负责医疗器械R&D零部件及产品的设计工作, 确保产品符合性能, 法律法规, 以及客户要求 提供符合要求的各项文件
Design Function 设计工程
1、Based on the requirements of ISO 13485 build the design &development process for the multi center NMD organization and secure the design & development records are documented and controlled. Ensure the design comply with the applicable statutory and regulatory requirements. This can include: EN standards, ISO standards,other(European regulation and SFDA requirements.) 基于ISO13485要求以及多地域医疗器械组织架构建立设计和开发流程，并负责设计和开发记录的归档和管控。保证设计全过程符合法律法规要求（包括欧盟标准规和ISO标准）。
2、Determine the user & design requirements in close cooperation with the central R&D center and relevant departments. Ensure user requirements to be understood properly by supplier through technical support to SSD. 与R&D 总部及相关部门紧密协作，制定正确的用户需求；协助SSD部门完成供应商的技术沟通，确保供应商能正确了解用户需求。
3、Based on the input from Marketing, Manufacturing, Quality, and Sourcing department, design and develop the new products as per the established procedures as agreed and documented in the QMS基于市场，生产，质量及采购等相关部门的输入，依据质量管理体系建立的流程设计开发新的产品。
4、Draft or give input to the design Input / Output, validation & verification and getting the approval from Europe R&D center and other central functions as documented in the QMS . Following the implementation. 起草设计的输入, 输出,验证文件, 并确保其得到R&D总部及其他相关部门的批准，并跟进后续的执行。
Project Function 项目功能
1、Lead development projects. 主导研发项目。
2、Support and give input following the project development process. Input can be: user requirement, test protocol, risk assessments, assess suppliers and test results, give guidance and support in case of deviations , In-House test.在研发项目过程中支持并提供输入，包括：用户需求、风险评估、评估供应商及其测试结果、解决偏差问题的指导和支持、工厂内部的测试。
Risk Management and Dossier Control 风险管理及文档控制
1、Contribute to the Risk Assessment of R&D activities Support the RA function as to ensure the national and international statutory and regulations requirement are met.参与各项开发工作的风险评估，协助RA部门确保设计的产品符合国家和国际法规要求。
2、Support the RA function as to ensure the dossier submission to Notified Body / authority (e.g. DEKRA, SFDA, etc.) are in time and completed with the necessary design inputs. 协助RA部门保证与政府授权部门（如DEKRA， SFDA）沟通的设计文件及时提交。

岗位要求：

1、Bachelor degree education or above, with majored in Engineering, the polymer background preferred.本科以上学历，工科背景，高分子材料专业优先。
2、3+ years related the plastic injection molding and the Medical Devices. Experience in international company is preferred.3年以上医疗器械和塑胶件相关工作经验，有外资工作经验者优先。
3、Be familiar with the R&D process of the plastic injection products and tooling.熟悉塑胶件研发及模具开发过程。
4、Be skilled with AutoCAD and Solid Works. And / or Pro_E, UG.熟练操作AutoCAD及Solid Works和/或Pro_E和/或UG等软件
5、Knowledge of the international standard for quality system and regulation affairs of medical device, e.g. ISO 13485. 了解相关医疗器械的一些国际标准质量体系及法规事务，如ISO13485
6、Proficient English communication skill (written and verbal) 良好的英语听、说、读、写能力

纽迪希亚于1995年进入中国市场，并于2000年1月设立工厂并正式投产。这是一家向欧美市场出口肠内营养产品及配套产品的公司，同时也是纽迪希亚全球三大生产基地之一。
纽迪希亚是中国肠内营养理念推广与传播的先行者，目前已经完成了 研发、生产、营销、服务等完整产业生态链的建设。公司主要生产经营肠内临床营养产品（ECN）,肠内营养输注产品（Flocare）以及特殊医学用途配方食品（FSMP）。
纽迪希亚坚持以患者为中心，携手政府、医疗机构等社会各方力量，致力于通过创新的产品和业务模式，推动中国医学营养产业的发展，帮助患者延长生命，享受更健康，更有尊严的生活。