Qualifications
1.	Bachelor's degree in Mechanical, Manufacturing, Automation, Mechatronics, Electrical, Industrial Engineering, or a related field.
2.	5+ years of experience in manufacturing engineering, automation, equipment, or process engineering preferred.
3.	Experience with automated manufacturing equipment, including PLCs, servo systems, sensors, machine vision, electrical controls, and mechanical systems.
4.	Strong troubleshooting and root-cause analysis skills for manufacturing processes and equipment.
5.	Experience with manufacturing process development, equipment/process validation, and continuous improvement.
6.	Knowledge of Lean Manufacturing, Statistical Process Control (SPC), process capability, and statistical problem-solving methods.
7.	Ability to read mechanical drawings, electrical schematics, and equipment documentation.
8.	Experience developing manufacturing documentation such as work instructions, equipment procedures, drawings, and process specifications.
9.	Experience in medical device, ISO 13485, FDA-regulated, or similarly controlled manufacturing environments preferred.
10.	Strong English communication skills and proficiency with Microsoft Office.
11.	2D & 3D CAD experience, such as AutoCAD and SolidWorks, is preferred.
Responsibilities
1.	Provide engineering support for day-to-day manufacturing operations, including troubleshooting equipment, process, quality, yield, and capacity issues.
2.	Lead and support automation equipment development, installation, commissioning, troubleshooting, validation, and transition into production.
3.	Develop and improve manufacturing processes to increase safety, quality, throughput, equipment reliability, and production efficiency.
4.	Support new product and process introductions, including equipment, tooling, fixtures, work instructions, production layouts, and manufacturing readiness.
5.	Develop and execute equipment and process validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities when applicable.
6.	Lead structured problem solving, root-cause analysis, Statistical Process Control (SPC), process-capability analysis, defect reduction, and corrective actions.
7.	Identify and implement Lean Manufacturing, automation, cost-reduction, and continuous-improvement opportunities.
8.	Participate in Design for Manufacturing (DFM), Design for Assembly (DFA), Process Failure Mode and Effects Analysis (pFMEA), and manufacturing risk reviews to ensure products and processes are robust and manufacturable.
9.	Develop and maintain manufacturing and equipment documentation, including work instructions, specifications, programs, drawings, preventive-maintenance requirements, and troubleshooting information.
10.	Work cross-functionally with Production, Quality, Engineering, Maintenance, suppliers, and equipment integrators to implement manufacturing projects.
11.	Support equipment safety, preventive maintenance, spare-parts planning, and long-term equipment reliability.
12.	Perform other responsibilities as assigned.


职位描述-制造与自动化工程师
资格
1.机械、制造、自动化、机电一体化、电气、工业工程或相关专业本科以上学历。
2.5年以上制造工程、自动化、设备或工艺工程经验优先。
3.有自动化制造设备的经验，包括PLC、伺服系统、传感器、机器视觉、电气控制和机械系统。
4.对制造工艺和设备有较强的故障排除和根本原因分析能力。
5.具有制造工艺开发、设备/工艺验证和持续改进的经验。
6.了解精益制造、统计过程控制（SPC）、过程能力和统计问题解决方法。
7.能够阅读机械图纸、电气原理图和设备文件。
8.有开发制造文件的经验，如工作说明、设备程序、图纸和工艺规范。
9.有医疗器械、ISO 13485、FDA监管或类似受控制造环境经验者优先。
10.英语沟通能力强，熟练使用微软办公软件。
11.有二维和三维CAD经验，如AutoCAD和SolidWorks，优先考虑。
职责
1.为日常制造操作提供工程支持，包括排除设备、工艺、质量、产量和产能问题。
2.领导和支持自动化设备的开发、安装、调试、故障排除、验证和投入生产。
3.开发和改进制造工艺，以提高安全性、质量、吞吐量、设备可靠性和生产效率。
4.支持新产品和工艺介绍，包括设备、工具、夹具、工作说明、生产布局和制造准备。
5.开发和执行设备和工艺验证，包括安装确认（IQ）、运行确认（OQ）和性能确认（PQ）活动（如适用）。
6.领导结构化问题解决、根本原因分析、统计过程控制（SPC）、过程能力分析、缺陷减少和纠正措施。
7.识别并实施精益制造、自动化、降低成本和持续改进的机会。
8.参与制造设计（DFM）、装配设计（DFA）、工艺失效模式和影响分析（pFMEA）以及制造风险审查，以确保产品和工艺的稳健性和可制造性。
9.制定和维护制造和设备文件，包括工作说明、规范、程序、图纸、预防性维护要求和故障排除信息。
10.与生产、质量、工程、维护、供应商和设备集成商跨职能合作，实施制造项目。
11.支持设备安全、预防性维护、备件规划和长期设备可靠性。
12.履行分配的其他职责。