KEY RESPONSIBILITIES / DUTIES 主��责:
- Â Provides Engineering knowledge support to a process, project or other function. Knows and applies fundamental Engineering and Quality Management System concepts, practices and procedures.
æ��供工程知识，支æŒ�工艺开å�‘ã€�项目å�Šå…¶ä»–部门，熟知质é‡�管ç�†ç³»ç»Ÿç�†å¿µ，实践和æµ�程
- Ensure quality of process and product as defined in appropriate OS and Material specifications.
ä¿�è¯�工艺，产å“�è´¨é‡�满足æ“�作系统å�Šæ��æ–™è§„æ ¼è¦�求
- Ensure GMPs and system safety.
��GMP 执行�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å¼�å�Šåˆ†æž�, 控制计划，æ ‡å‡†ä½œä¸šç¨‹åº�，生产批准æµ�程生æˆ�，有关产å“�转移å�Šæ‰©å±•ã€‚
- Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
支æŒ�固定资产的投资，设备选型，å�ˆå�Œè°ˆåˆ¤，安装验è¯�
- Provide training for manufacturing team members.
为生产团队æ��供培è®
- Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.
é…�å�ˆæ��料技术，设计，è´¨é‡�ä¿�è¯�部门å�Šæ—¶ç»™å®¢æˆ·æ��供高质é‡�产å“�
- Communicate and participate in system and process troubleshooting with support team members and with external agents.
支æŒ�团队å�Šå¤–部代ç�†å•†，沟通和å�‚与系统å�Šå·¥è‰ºé—®é¢˜è§£å†³
- Lead and participate cross functional and cross divisional process improvement initiatives.
领导å�Šå�‚åŠ è·¨è�Œèƒ½è·¨éƒ¨é—¨çš„工艺改善活动
- Identify, quantify, and implement opportunities to reduce cost of goods
识别，é‡�化，和实施改善机会，å‡�少产å“�æˆ�本
- Provide engineering support to the Advanced Operations (AO) team for new Product and new process introduction.
新产å“�，新工艺的引入，æ��供工程技术支æŒ�AO团队
- Conduct Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
ç–划实施对产å“�å�Šå·¥è‰ºè¿›è¡ŒéªŒè¯�，安装验è¯�，工艺验è¯�的相关文件
- Conduct Gauge R&R studies for products and new processes.
对新产å“�新工艺,ç–化实施é‡�å…·é‡�测系统分æž�
- Application and development of statistical tools for use in driving continuous improvement projects.
应用和开å�‘统计工具的使用推动æŒ�ç»æ”¹å–„项目，
- Manage non-conformities (NC) and Corrective/Preventive Actions (CAPA) with the QA departments
和质é‡�部门处ç�†NC，CAPA
- All other duties as assigned.
执行其他被安排的任务
SUPERVISORY RESPONSIBILITIES 管��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 å²—ä½�技能：
- Business understanding of operations and there impacts essential.
ç�†è§£è¿�è�¥ä¸šåŠ¡å�Šå½±å“�è¦�ç´
- High level of PC Skills required.
高水平的电脑应用能力
- Flexibility essential.
必��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æž�解决问题的能力，å�¯ä»¥åœ¨å¿«èŠ‚å¥�ä¸å¤„ç�†å¤šä¸ªå·¥ä½œ
- 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ä¸å·¥ä½œ
- Green Belt 6 Sigma qualifications required
6 Sigma ç»¿å¸¦èµ„æ ¼è®¤è¯�
- 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è�Œèƒ½éƒ¨é—¨，å’ŒAO,è´¨é‡�ç‰éƒ¨é—¨å�ˆä½œ
- Fluent English writing and speaking
英文写说�利
- Project Management skills
项目管�技能
RELEVANT EXPERIENCE
ç»�验è¦�求：
- Has 0- 2 years’ experience in a manufacturing environment.
åœ¨åˆ¶é€ çŽ¯å¢ƒä¸æœ‰0~2年的工作ç»�验
- Experience in an FDA regulated or regulated industry beneficial.
有FDA 法规�监管规范�验
- Â Experience in a six sigma and Lean Manufacturing environment with proven improvement results.
有6 sigma�精益生产�改善项目的�验
EDUCATION
教育背景：
- B.S or master  in Engineering preferred
机械工程本科或硕士å¦åŽ†ä¼˜å…ˆè€ƒè™‘
Travel Percentage: None