Process Engineer 工艺验证工程师

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 工作综述 Job Summary

The overall responsibility of this position is to focus on production support, continuous improvement, and cost saving. For New Product Introductions (NPI) and Product Transfers, to develop a complete transfer package for handover to Operations/Supply Chain. To ensure that production is at steady state before the NPIs/transfers are complete. 此职位全部职责在于专注于生产支持、持续改善、成本节约和在JB内部移交给生产组织，建立一个完整的传输包。确保在项目转移完成前生产保持定态。




工作职责 Responsibilities

? Develops, evaluates, and improves manufacturing methods as it relates to both new product and current product. Confers with operation staff concerning process improvement and tooling to ensure efficient production methods. Conducts root cause analysis investigations. 开发、估算并提高联系新产品和现有产品的制造方法。与生产员工就过程改进和工装上进行讨论以确保高效的生产方法，进行根本原因分析调查。
? Leads/guides production team to include Manufacturing, EOL, Packaging areas to improve processes, quality and productivity. 引导、指导生产团队，包括制造、后处理、包装区域，过程改善、提高质量和生产效率。
? Leads and participates in Lean/ Continuous Improvement events. 负责产品转移的制造工艺开发，建立和更新。
?Responsible for developing the complete manufacturing process for the transferred product group, establish and update: 负责产品转移的制造工艺开发，建立和更新。
? BOMs and Routes 物料配方和工艺
? Process flow chart 工艺流程图
? Tooling: Tools needed, tooling life programs 工装：需要的工具、刀具寿命
? Fixture development 夹具开发
? Equipment Preventative Maintenance checklists 设备预防性维修清单
? Machine and labor time standards 规范化机器和加工时间
? Print translation 图纸转换
? Process validation protocol/report 工艺验证协议、报告
? Process Spec and SOP development 工艺规范和SOP建立
? Creates and maintains accurate Design Master Records (DMR) that demonstrate a clear link between Design Specifications and Process/Material Specifications. 创建和维护准确的设计规范和过程/材料规范的器械主文档
? Responsible for overseeing and advising vendors on the development of outsourced processes during transfer/NPI phase. This includes, but is not limited to, reviewing and providing input on validations, assisting to troubleshoot problems, and reviewing/mitigating potential failure modes. 在项目转移/新产品导入阶段负责监督和指导外协工艺（如：清洗、包装，灭菌等）包括但不限于，评估和提供验证输入，协助解决问题，评估/减少潜在失效模式。
? Troubleshoots equipment issues and process development during start-up 项目初始阶段设备故障排除和工艺开发
? CAPA follow-up and deviation follow-up during transfer, start-up and production 项目初始阶段和生产中CAPA和偏离的跟踪
? Review Document Change Requests (DCR's), Non-conformances (NC’s), and critical maintenance forms for validation and FMECA implications and for approval. 审查文件的变更要求（ECR），不合格（NC’s）评审和关键的维修确认表，评审FMECA的影响并得到批准
? Plan, create, and execute validations (IQ/OQ/PQ), FAI during start-up and risk analyses (PFMECA’s) in accordance with FDA and ISO harmonized standards. 计划、创建并执行确认（IQ/OQ/PQ），项目初始阶段的FAI和按照FDA和ISO统一标准风险分析（PFMECA）。
? Prepare technical reports and feasibility studies. 准备技术性报告和可行性研究
?Provide and analyze detailed estimates of production time/ standard cost and other related costs to assist management. 提供和分析详细的估算生产时间/标准成本及其他相关费用，以协助管理
? Train manufacturing personnel on new processes or procedures, WIs as required 用必要的作业指导书对制造人员提供新工艺和程序的培训
?Ensure that personal safety equipment is utilized and maintained properly. 确保个人安全设施， 确保适当地使用维护



? Degree or equivalent in engineering or relevant technical discipline is prefer 工程或相关技术学科的学士学位或以上优先
? Good written/verbal English communication skills 良好的书面/口头英语沟通技巧
? Good interpersonal skills 良好的人际交往能力
? Independently capable of managing tasks for multiple project plans simultaneously 同时能够独立管理多个项目的任务计划
? Independently capable of performing logical problem solving 独立执行逻辑解决问题的能力
?Familiar with ISO 11607 熟悉ISO 11607的法规要求
?Experience in cleanroom management 有洁净室管理经验
? Basic understanding of metals, metalworking and stress/failure of metals 具备材料知识，金属加工和材料失效分析
? Professional and ethical conduct 职业和道德行为
? Committed to strive for excellence in the execution of required responsibilities 致力于追求卓越在执行中所需要的责任
? Committed to continuously improve English communication skills and cultural awareness 致力于不断提高英语沟通技巧和文化意识
? Committed to continuously learn as needed to perform the required responsibilities 致力于不断学习，需要履行必要的责任
? Learn the regulatory requirements for the Medical Device Industry 学习了解医疗行业的监管要求