Senior Manufacturing Engineer
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
Travel Percentage: 10%