Process Engineer, Orthopedics

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• Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
• Recommend, design, select machinery, tools, jigs, and fixtures required to machining the products.
• 建议、设计、选择加工产品所需的机械设备、刀具、工装与夹具。
• Work with other Manufacturing Engineers to maintain the item master, product routings and bills of material in the MRP system.
• 与其他制造工程师合作，在MRP系统中维护条款主文件、产品工艺路径和物料清单
• Deliver necessary training for workshop employees;
• 为车间员工提供必要的培训;
• Responsible for continuous improvement initiatives, such as projects to improve quality, cost, delivery and efficiency.
• 负责持续改进举措，例如改进质量、成本、交付和效率的项目
• Use PE principles to improve processes and reduce non-value-added waste and activities. (Including process FMEA, Gauge R&R, Predictive Indicator and use of statistical techniques).
• 使用PE原则来改进流程并减少非附加值的浪费和活动。（包括过程FMEA，Gauge R＆R，预测指标和统计技术的使用）。
• Participate to identify capital spend and budget requirements.
• 参与确定资本支出和预算需求。
• Participate or lead layout design / implementation for facility and equipment.
• 参与或领导设施和设备的布局设计/实施
• Support R&D on new products development and quality system implementation.
• 支持新产品开发和质量体系实施
• Understand the Quality philosophy based on FDA QSRs, ISO 9000 and SFDA requirements.
• 理解基于FDA QSR，ISO 9000和SFDA要求的质量理念
• Understand, compile and control non-conformance data and product tractability.
• 理解、编制和控制非符合项数据和产品易追溯性
• Responsible for creating and maintaining manufacturing documentation for equipment and processes.
• 负责创建和维护设备和流程的制造文件
• Responsible for compiling the validation/verification protocols and completing studies by creating finished reports.
• 负责编制验证/确认协议，并创建完成的报告完成研究。
• Understand special processes requirements are plus, such as Sterilization, Cleaning, Packaging, FPI etc.
• 理解特殊工艺要求是加成，如灭菌，清洁，包装，FPI等...
• Understand computer software validation requirements.
• 理解计算机软件验证要求
• Perform all job duties in full accordance with:
• 按照以下要求履行工作职责：
• The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information.
• 基于强生对信息、资产保护、密码保密以及关键业务信息的政策
• All J&J policies and local regulations.
• 所有强生的政策和当地法规
• The policies of the Health Care and Environmental programs.
• 健康和环境方案的政策
• The code of conduct policies.
• 行为准则政策
• Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc.
• 对所有审核（内部、公司、外部、质量健康与安全、环境等）负全部责任和所有权（和现场员工一样）

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Preferred Skills: