松月电子

职位描述：

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。

职位描述：

一、Responsibility岗位职责：
1. Quality Management System (QMS): ISO13485 maintenance, FDA QMSR compliance, CAPA management, Change management.
质量管理体系（QMS）：ISO13485 体系维护，确保符合 FDA QMSR 法规要求，CAPA（纠正预防措施）管理，变更管理。
2. Internal & External Audits: Plan and coordinate internal audit activities,Prepare audit reports and follow-up actions, Support external audits conducted, Track audit findings and verify completion of corrective actions.
内外部审核：策划并协调内审工作，编制审核报告并跟进整改行动，配合开展外部审核，跟踪审核发现项，验证纠正措施完成情况。
3. Document Control: Maintain controlled documents and quality records in Unipoint, Ensure document revision control and timely release of approved documents, Support ECN/ECO implementation and document change activities.
文件控制：在 Unipoint 系统中维护受控文件与质量记录，管控文件版本，确保批准文件及时发放，支持 ECN/ECO 执行及文件变更相关工作。
4. Complaint & NCR: Customer complaint investigation, NCR/SCAR follow-up.
客诉与不合格项：客户投诉调查，NCR/SCAR 跟进。
5. Quality Control Support: QC procedure maintenance, QC training, Review QC reports and quality metrics.
质量控制支持：QC 程序文件维护，QC 相关培训，审核 QC 报告及质量指标。
6. Continuous Improvement: NPI（New Product Introduction）, quality support，eg，translate English ECN,ECO to Chinese, Process improvement, Equipment validation.
持续改善：NPI（新产品导入），质量支持，例如英文 ECN、ECO 文件翻译成中文，工艺改善，设备验证。

二、Qualification任职要求：
1. Bachelor’s degree in engineering, Quality Management, Biomedical Engineering, Manufacturing, or related field.
工程、质量管理、生物医学工程、制造或相关领域的学士学位。
2. Minimum 2 years of experience in Quality Assurance within a medical device or regulated manufacturing environment.
至少 2 年医疗器械或受法规管控生产环境下的质量保证工作经验。
3. Good team spirit, cooperative.
良好的团队精神和协作能力。
4. Good working attitude, conscientious.
良好的工作态度，做事认真负责。
5. Good English speaking, listening, and written.
良好的英语听说读写能力。
6. Received quality related training will be good, such as internal audit, ISO 13485,QMSR.
接受过内审、ISO 13485、QMSR 等质量相关培训者优先。
7. Rich knowledge of SPC,6Sigma, Gauge R&R, QC tools.
精通统计过程控制（SPC）、六西格玛、测量系统分析（Gauge R&R）及各类质量控制工具。
8. Rich Medical device quality control experience, know ISO13485 rules, or have knowledge of FDA QMSR requirements.
具备丰富的医疗器械质量管控经验，熟悉 ISO13485 规范，或了解美国 FDA 质量体系法规（QMSR）要求。
9. Polite and in good manner, comply with company discipline.
为人有礼，遵守公司规章制度。