KEY RESPONSIBILITIES / DUTIES主要职责:

•  Provides Engineering knowledge support to a process, project or other function. Knows and applies fundamental Engineering and Quality Management System concepts, practices and procedures.

提供工程知识，支持工艺开发、项目及其他部门，熟知质量管理系统理念，实践和流程

• Ensure quality of process and product as defined in appropriate OS and Material specifications.

保证工艺，产品质量满足操作系统及材料规格要求

• Ensure GMPs and system safety.

保证GMP 执行及系统安全

• Lead PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and scale ups.

领导过程失效模式及分析, 控制计划，标准作业程序，生产批准流程生成，有关产品转移及扩展。

• Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.

支持固定资产的投资，设备选型，合同谈判，安装验证

• Provide training for manufacturing team members.

为生产团队提供培训

• Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.

配合材料技术，设计，质量保证部门及时给客户提供高质量产品

• Communicate and participate in system and process troubleshooting with support team members and with external agents.

支持团队及外部代理商，沟通和参与系统及工艺问题解决

• Lead and participate cross functional and cross divisional process improvement initiatives.

领导及参加跨职能跨部门的工艺改善活动

• Identify, quantify, and implement opportunities to reduce cost of goods

识别，量化，和实施改善机会，减少产品成本

• Provide engineering support to the Advanced Operations (AO) team for new Product and new process introduction.

新产品，新工艺的引入，提供工程技术支持AO团队

• Conduct Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.

策划实施对产品及工艺进行验证，安装验证，工艺验证的相关文件

• Conduct Gauge R&R studies for products and new processes.

对新产品新工艺,策化实施量具量测系统分析

• Application and development of statistical tools for use in driving continuous improvement projects.

应用和开发统计工具的使用推动持续改善项目，

• Manage non-conformities (NC) and Corrective/Preventive Actions (CAPA) with the QA departments

和质量部门处理NC，CAPA

• All other duties as assigned.

执行其他被安排的任务

SUPERVISORY RESPONSIBILITIES管理职责:

• May lead one or more engineering technicians and/or manufacturing engineers.

能领导一个或更多技术员和工程师

REQUIRED SKILL SET岗位技能：

• Business understanding of operations and there impacts essential.

理解运营业务及影响要素

• High level of PC Skills required.

高水平的电脑应用能力

• Flexibility essential.

必要灵活性

• Strong communication skills with both internal and external stakeholders.

对内外部客户有很强的沟通技能

• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.

具有高效的分析解决问题的能力，可以在快节奏中处理多个工作

• The individual should enjoy working in a dynamic and results motivated team environment.

喜欢在有动力，自我驱动的环境中工作

• Green Belt 6 Sigma qualifications required

6 Sigma 绿带资格认证

• Black Belt 6 Sigma an advantage.

6 Sigma 黑带更好

• Ability to effectively work cross-functionally with A.O, Quality, etc.

有效的和跨职能部门，和AO,质量等部门合作

• Fluent English writing and speaking

英文写说流利

• Project Management skills

项目管理技能

RELEVANT EXPERIENCE

经验要求：

• Has 2- 5years’ experience in a manufacturing environment.

在制造环境中有2~5年的工作经验

• Experience in an FDA regulated or regulated industry beneficial.

有FDA 法规及监管规范经验

•  Experience in a six sigma and Lean Manufacturing environment with proven improvement results.

有6 sigma及精益生产及改善项目的经验

EDUCATION

教育背景：

• B.S or master  in Engineering preferred

机械工程本科或硕士学历优先考虑