(Senior) Manufacturing Engineer

Provide advanced technical and engineering support to a project or function. This engineer will have the required engineering competencies and systems training to support a manufacturing area or project 给项目及部门提供先进的技术和工程支持。这个工程师将有工程职业能力和系统培训支持制造业区域或项目 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. 配合材料学，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. 和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，提供工程技术支持给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. 策化实施量具量测系统分析对新产品新工艺 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 Responsible for assisting in the development of a global team that is proficient in process improvement and problem solving manufacturing issues using Six-Sigma tools 负责协助全球的开发团队,精通流程改进和解决问题，使用六西格玛工具解决制造问题 Providing technical leadership on all product and process issues 提供技术领导力在所有产品及工艺问题 Leading technical improvements under the business’s Continuous Improvement Program (CIP) 按照业务持续改进流程，领导技术改进 Provision of technical leadership/guidance for the Process / maintenance Technicians and other Manufacturing / Equipment Engineers on the team 提供技术领导/指导/维修技术员和其他生产过程/设备工程师团队 Responsibility for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and operational handover as appropriate 负责项目(价值流和跨职能)的任务,包括范围、审批、预算、规范,执行适当的资格和业务交接 Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good team work in support of the day to day operating requirements, and in pursuit of achieving the business targets 积极与跨职能团队成员和第三方供应商,并且总是良好的团队协同合作的支持日常的操作要求,并追求实现业务目标 Fostering a work environment of continuous improvement that supports SYK’s Quality Policy, Quality System, and the appropriate regulations for the area they support, in particular ensuring that employees are trained to do their work and their training is documented 促进持续改进的工作环境,支持史赛克的质量政策,质量系统,和适当的法规,确保员工被培训并做好的培训记录 Project management, resource prioritization, demonstrated experience in the development and execution of project plans (including time, budget and quality metrics) will be appreciated 项目管理、资源优化、经验应用与项目的计划和开发阶段(包括时间、预算和质量指标) Demonstrate proficiency in quality & regulatory compliance 熟知质量和法规合规性 Undertaking, where appropriate, a Subject Matter Expert’s role 主题专家角色在需要的时间 Coach Associate Engineer & Engineer in their development 指导助理工程师和工程师，帮助他们发展 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： Has very good oral and written communication skills. 有很好的口头和书面沟通技巧。 Has very good presentation skills. 有很好的表达能力 Professional in technical writing (e.g. process validation protocols, technical reports) 有专业技术写作(如工艺验证协议,技术报告) Professional in problem solving skills and has a passion to improve, he is creating new ideas help to improve. 专业的解决问题的能力和热情, Professional project management skills. 有专业的项目管理技能。 English reading and writing is a must, oral communication should be possible. 英语读，写，说能力 Strong communication and influencing skills with both internal and external agents 较强的沟通影响能力对内对外。 Capable of technical leading, influencing and providing technical direction to Engineers, Coop Students, Technicians and operators as required 领先的技术能力,影响并提供工程师提供技术方向, 必要时协助学生,技术员和操作员。 Technological pioneer, willing to source, investigate and implement technological advances 技术先锋,意愿调查和实施技术的进步 Confident and effective decision maker, with a proven leadership ability to negotiate and influence others 自信有效的决策者，有较强的领导力去谈判和影响他人 RELEVANT EXPERIENCE 经验要求： 5+ years related experience is a plus. Strong technical background. 五年工作经验及很强的技术背景优先考虑 Experience in CNC or other manufacturing processes. 有CNC及机械加工经验 Experience in developing and working with small group problem solving teams. 有领导团队解决问题的经验 Experience on process development. Experience medical device industry is preferred. 有工艺开发经验，医疗行业优先 Experience on process quality. 有质量过程管控经验 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 ISO 13485/Quality Systems Expertise and Application ISO13485质量体系专家 GMP/Medical Device Industry Expertise is preferred. 医疗行业经验优先 Lean/SPC is preferred. 精益／SPC 优先