高级研发工程师

日期:2022-04-06

岗位职责：

Customer Requirement Collection and Analysis.
客户需求收集与分析。
Interface with clinicians to identify unmet clinical needs.
积极与临床医生沟通，识别尚未满足的临床需求。
Gather input from clinical, marketing, literature and other sources.
从临床、市场、文献或其他来源中收集信息。
On market product’s benchmark.
已上市产品的对比测试。
Hands-on work to build early concept prototypes.
制作前期概念样品。
Advanced material definition and Supplier selection, design phases component quality management.
早期材料选型，供应商选择，设计阶段零部件质量管理。
Product concept creation, selection and refine.
产品原型设计、选择与优化。
Modeling and Drawing review and release, component specification creation and release.
模型建立，图纸创建，零部件要求确认与发布。
Product specification definition and maintenance.
产品技术指标定义与维护。
Technical feasibility analysis and tests.
技术可行性研究与测试。
Design, develop, and refine new products and processes in R&D lab.
在研发实验室中设计、开发并完善新产品和新工艺流程。
Develop and validate test methods.
开发并验证测试方法。
Conduct design verification and validation, including animal study and physician validation.
执行产品设计验证和确认，包括动物实验和医生验证。
Write and execute test protocols, analyze test data, write test reports.
编写并执行测试方案，分析测试数据，完成测试报告。
Perform User and Design FMECA.
进行设计、工艺的 FMECA 分析。
Create procedure, BOM, router, draft drawings compliant to standards with Cross functional support.
跨部门合作进行设计产品工艺流程、物料清单、流转卡和图纸。
Identify process requirement, development and improve process parameters with Cross functional support.
通过跨部门合作完成工艺需求，开发，优化工艺参数。
Identify problems and recommend solutions, continue design optimization.
发现问题并提出可行性解决方案，持续优化设计。
New idea collection during projects execution.
项目执行过程中收集新想法。
Patent draft and application.
专利撰写与申请。

岗位要求：

Minimum bachelor in engineering or similar，Master is a plus. 985，211 university is a plus.
工程类相关专业本科及以上学历，硕士学历优先，985,211大学优先。
5 years of experience in medical device process and design.
有 5年的医疗器械工艺和设计经验。
Design thinking and design of experiments knowledge.
具有设计思维与实验设计知识。
Experience with neurovascular implant processing and design is a plus.
有神经介入器械工艺和设计的经验优先。
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.
具有独立工作和有效管理时间的能力。
Strong analytical, organizational skills and teamwork.
具有较强的分析能力，组织能力和团队合作能力。
Proficient in Microsoft Office Suite, Adobe Reader, SolidWorks.
能熟练运用 office、Adobe Reader、SolidWorks软件。
Understanding GMP and ISO 13485, FDA/CE regulatory requirements for product testing.
了解 GMP 和 ISO 13485 法规标准, 以及FDA/CE 对产品测试的要求以及法规监管要求。
Presentation skill is a plus.
演讲技巧优良者优先。
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 is a plus.
优秀的英文表达能力，对神经介入方面有丰富的词汇量优先。

位置：

中国上海

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hr@wallabymedical.com