日期:2021-03-30
Design, develop, and refine new products and processes.
设计、开发和完善新产品流程。
Hands-on work to build early concept prototypes.
完成早期概念原型。
Develop and validate test methods.
开发和验证测试方法。
Conduct product verification, validation & qualification testing.
进行产品验证、确认以及性能测试。
Identify process requirement, develop and improve process parameters.
根据工艺需求,开发和优化工艺参数。
Identify and improve equipment for product development and testing.
为产品开发和性能测试准备相应的设备,并对设备功能进行优化。
Write and execute test protocols, analyze test data, write test reports.
编写测试方案,分析测试数据,编写测试报告。
Perform design and process FMEA.
进行设计、工艺的FMECA分析。
Create procedure, BOM, router, draft drawings compliant to standards.
设计工艺流程,物料清单,流转卡和图纸。
Communicate with vendors to determine material requirement, and perform supplier quality management.
与供应商沟通,确定材料要求,并执行供应商质量管理。
Work closely with other functional groups to identify and coordinate efforts.
与其他职能部门紧密合作。
Identify problems and recommend solutions.
发现问题并提出可行性方案。
Interface with clinicians to identify novel solutions to clinical problems.
与临床医生积极沟通,识别解决临床问题的新方法。
Gather input from clinical, marketing, literature and other sources.
收集来自临床、市场、资料文献等信息,与医生积极沟通并获得反馈信息。
Manufacturing transfer.
参与项目转移。
Minimum bachelor’s in engineering.
工程类本科及以上学历。
5-8 years of experience in medical device process and design.
有5-8年医疗器械生产、设计经验。
Experience with neurovascular implant processing and design.
有参与和设计神经介入器械的经验。
In depth understanding of neurovascular coils.
对颅内弹簧圈有深刻的理解。
Experience with mechanical detachment systems.
有操作机械解脱系统的经验。
Self-starter, driven to take initiatives to solve problems.
能积极主动采取行动解决问题。
Ability to work independently and management time effectively.
独立工作、有效管理时间的能力。
Strong analytical and organizational skills.
较强的分析能力和组织能力。
Proficient in Microsoft Office Suite, Adobe Reader, SolidWorks.
能熟练运用office、Adobe Reader、SolidWorks。
Understanding GMP and ISO 13485.
了解GMP和ISO 13485法规标准。
Understand FDA/CE regulatory requirements for product testing.
了解FDA/CE的产品测试要求以及法规监管要求。
Proficient email communication with US/European suppliers in English.
能使用邮件与美国及欧洲供应商进行英文无障碍沟通。
Excellent verbal English, excellent vocabulary in technical neurovascular discussion.
优秀的英文表达能力,对神经介入方面有丰富的词汇量。
中国上海