Description/职位描述:

o 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。

o 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

o Deliver necessary training for workshop employees;

为车间员工提供必要的培训;

o 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

o 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）。

o Participate to identify capital spend and budget requirements.

参与确定资本支出和预算需求。

o 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

o 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

o 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

o 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

o 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

o 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。

o 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...

o Understand computer software validation requirements.

理解计算机软件验证要求

o 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

Qualifications/任职要求:

§ Experience in engineering function / 在工程部门的工作经验

§ CNC machining process and programming /　CNC机加工工艺和编程

§ Tool, jig and fixture design and selection / 工具、夹具和治具的设计和选择