高级研发工程师-医疗器械

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高级研发工程师-医疗器械

纽迪希亚贸易（上海）有限公司

无锡

本科
02-23 发布

职位信息

职位名称：高级研发工程师-医疗器械

类别名称：

职位描述：

职位描述：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.开展相关医疗器械产品的开发和改进项目，为项目管理和成本控制做出专业性贡献；确保产品符合法律法规,性能指标及客户要求。负责医疗器械零部件开发和验证工作，包括用户需求的导入，产品性能参数标准的制定，项目全程风险评估以及管控，保证合格零部件的批量生产。Project management项目管理1. Identify and explore opportunities and implement projects for cost evolution, or product quality improvement, ensure relevant project comply with high quality and efficiency.开发并主导完成成本控制、产品改进等项目，确保项目按时有效地完成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.协调跨部门之间的合作，主导大项目的开展，例如：公司层面的优化设计直至自动化生产和可持续发展等一些长期性项目。Product design and component development医疗器械设计与零部件开发工作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.较好地了解医疗行业零件和成品的相关设计的国内国际ISO标准，熟悉并掌握与标准相关的产品测试要求。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.能够根据标准要求，以及市场，法律法规，生产，质量及采购等相关部门的输入，完成现有零件及成品设计。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.与R&D总部及相关部门紧密协作，制定正确的用户需求。定期检查供应商项目开发进程，保证用户需求的正确执行。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.参与并组织风险评估活动，起草产品确认所需的测试需求，评估供应商测试结果，并提出偏差整改要求。负责完成In-House的测试项目。Education & working experience 学历与工作经验要求：1.Master degree education or above, with majored in Engineering, the mechanical and polymer background preferred.硕士以上学历, 工科背景，机械设计和高分子材料类专业优先2.5+ years related the plastic injection molding and the Medical Devices. Experience in international company preferred.5年以上塑胶件注塑和医疗器械行业工作经历，有外资工作经验者优先3.Capable to manage small or medium projects.有较好的项目管理经验Occupational qualifications职业资格要求：1.Be familiar with plastic materials injection process and plastic product automation assembly.具备殷实的塑料注塑成型工艺相关知识，和良好的零件设计、优化技能2.Knowledge of the standard for quality system, e.g. ISO 13485. Be familiar with the ISO10993.了解一些标准质量体系，如ISO13485；熟悉ISO10993或等同法规3.Proficient English communication skill (written and verbal)良好的英语听、说、读、写能力4.Excellent MS office skills能够熟练使用办公软件

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