东莞 [切换城市] 东莞招聘

新产品开发工程师 NPD Engineer

卡莱医疗科技(东莞)有限公司

  • 公司规模:1000-5000人
  • 公司性质:外资(欧美)
  • 公司行业:电子技术/半导体/集成电路

职位信息

  • 发布日期:2021-01-13
  • 工作地点:东莞
  • 招聘人数:1人
  • 工作经验:5-7年经验
  • 学历要求:大专
  • 语言要求:英语良好
  • 职位月薪:13-18万/年
  • 职位类别:项目工程师

职位描述

1. 新产品可行性评估,配合采购/PE/QE/销售完成RFQ相关工作,并提供报价给业务。
Feasibility evaluation of new products, cooperate with sourcing /PE/QE/sales to finish RFQ related works and provide quotation to sales.
2. 与研发/PE团队一起主导客户需求研究,支持客户进行产品设计。
Leading study on customer requirements with Design/PE team, supporting customer on product design.
3. 主导新产品导入初期时DFM评审,识别风险,提供可制造性改善方案,将可制造性改善建议和AE/客户沟通,达成DFM设计优化方案。
Leading DFM review at early stage of new product introduce, Identify risks and provide solution to improve manufacturability, share the DFM proposal report with AE/customer to achieve the optimized design solution.
4. 支持维护产品的故障排除,符合性纠正,就产品技术和规格和AE/客户沟通,主导产品变更。
Support the troubleshooting and Compliance correction for sustaining products, communicate the product technical and spec. issues with AE/customer, conduct product change.
5. 与供应商/AE/客户及其他部门沟通设计问题,为产品改进提供技术支持。
Communicate with suppliers/AE/customer and other departments about design issues, provide technical support to product improvement.
6.创建并领导MVP,跟进并完成项目开发所需的所有技术文件,包括工程图纸、规范、BOM、模具设计、CIPs、FAI等。
Create and Lead in MVP, follow and finish all the technical documents needed for project development,
including engineering drawings, specifications, BOM, Mold design, CIPs, FAI, etc.
7. 定义新材料的规格,指导检验,FAI报告评估,样品材料计划,样品制作,评估新模具设计,完成材料采购和开模申请单。
Define the specification of new material, instruct the inspection, FAI report evaluation, material planning for sample building, evaluate new mold design and initiate application request for procurement material and tooling
8. 监控样品制作过程并提供现场技术支持确保样品按进度交付,领导与客户沟通解决问题或偏差。
Monitoring and on site support prototype build to ensure shipment on schedule, lead the technical communicate with customer to solve problems and deviations.
9. 通过DCN/ECN发起产品资料变更、评估原材料/在制品和库存影响,并与相关部门沟通,维护产品相关的工程文件。
Initiate DCN/ECN for product document change, evaluation impact on raw material/WIP and inventory ,communicate with related departments, maintain all engineering documents.
10. 与项目经理一起制定项目计划,跟踪工程活动的进展。
Working with project manager on project plan creation, follow the progress of the engineering activities.
11. 参与V**E重大成本节约项目的识别,协助V**E 团队实现成本解决方案的落地。
Participate in identify the key V**E cost saving projects and support V**E team to achieve the target.
12. 参与新开发项目设计评审,识别特殊过程并协助质量部门评估特殊过程(IQ/OQ/PQ)验证协议的制定。
Participate in new project design review, identify the special process and support Quality team to finish the process validation protocol.
13. 参加项目多方电话会议,主导和客户沟通技术问题和解决方案。
Participate in the project Multi-parties conference call, conduct the communication for technical issues and solutions with customer.
14. 实现预定的行动来达成KPI 绩效目标。
Implement scheduled actions to achieve annual KPI performance target.
15. 根据所要求的TMV协议,进行并构建TMV坏/好的黄金样本进行测试系统验证。
Conduct and build TMV bad/good golden samples based on TMV protocol required.
16. 及时解决MDI(Management daily improvement)出现的问题,以支持生产正常运营。
Solve the problems comes from MDI/Stand meeting in timely manner to support daily operations
17. 确保符合医疗行业合规性(FDA/EU MDR/ISO 13485)。
Ensure medical industrial compliances (FDA/EU MDR/ISO 13485) are fulfilled.
18. 应用防呆理论,能将系统防呆方案运用到日常工作中。
Execute poka-yoke methodology and implement systematic (foolproof) solution into daily work.
19. 协助QE处理客户投诉及跟进CAPA事项。
Support Quality to handle customer complaint and CAPA related.


任职要求:
1. 机械工程或相关专业本科以上的学历。
Bachelor Degree in Mechanical Engineering or related science
2. 5年以上医疗装配或医疗行业相关工作经验。
5+ years of related experience in medical assembly scope or healthcare industry.
3. 熟悉IPC-620和IPC-610标准。
Familiar with IPC-620 and IPC-610 criteria.
4. 有电缆装配新产品导入背景者优先考虑
Has the NPI background of cable assembly is a plus for this position.
5. 具备扎实的工艺开发或产品设计经验
Has solid experience of process development or product design is required
6. 熟悉塑胶/金属材料特性及注塑加工工艺
Familiar with plastic/metal material characteristics and injection/ machining process
7. 具备电镀基础知识。
Has plating basic knowledges.
8. 熟练使用Solidworks 3D软件,熟练Office 软件。
Skillful for operation Solidworks 3D software, familiar with office (word/excel/ppt).
9. 熟悉Cpk计算和数据分析来解决问题。
Familiar with Cpk calculate and data analysis to solve problems.
10. 熟悉ISO13485标准者优先
Familiar with ISO13485 is preferred.
11. 英语4级或以上,口语可以作为工作语言和客户沟通,书面英语可以熟练处理文档和电邮。
CET-4 or above, Spoken English can be used as the working language to communicate with customers, and written English can handle documents and emails skillfully.
12. 具有团队精神和一定的抗压能力/快速反应能力.可以前瞻性的完成工作。
Have the team spirit and working under pressure/quickly response ability, be proactive in getting work done.
13. 熟悉问题分析工具6sigma/8D/5why/PFMEA/DFM。
Familiar with quality tools like 6sigma/8D/5why/PFMEA/DFM to resolve productions issues.

公司介绍

卡莱医疗科技(东莞)有限公司是,(以下简称卡莱医疗)是一家专业的医疗线材产品生产厂家。卡莱医疗隶属于美国卡莱集团。卡莱集团是一家实力排行在美国500强内的美国上市公司,旗下的股票业绩在美国纽约有非常出色的表现。

联系方式

  • 公司地址:桥头镇邓屋新湖工业园桥龙路2号 (邮编:523000)
  • 电话:15622259367