Manufacturing Engineer

Work Flexibility: Onsite

 KEY RESPONSIBILITIES / DUTIES主要职责:

·   Participate in the review of 2D drawings and 3D models in the R&D stage of new products, provide professional DFM optimization suggestions from the perspective of CNC precision machining. Evaluate structural rationality, dimensional tolerance, surface finish requirements and material machining difficulty, identify manufacturing risks in advance, and deliver formal process feasibility reports.

参与新产品研发阶段二维图纸、三维模型评审，从 CNC 精密加工角度输出专业 DFM 可制造性优化建议；评估结构合理性、尺寸公差、表面光洁度要求及材料加工难度，提前识别制造风险，输出正式工艺可行性报告。

Independently complete process scheme design, tool selection, and cutting parameter optimization for 5‑axis Milling, Mill Turn, Swiss Turn, 5-axis Grinding, ID/OD Grinding, Wire EDM, Turning, Gun drilling composite equipment. Conduct CAM programming and machining simulation via UG/NX, Esprit or Mastercam, follow up prototype trial production and first‑piece validation, and solve technical problems such as dimensional deviation, machining deformation, surface roughness defects and burrs in the trial stage.

独立完成五轴加工中心、车铣复合、纵切、五轴磨、内/外圆磨、线切割、数控车床、枪钻设备的工艺方案设计、刀具选型、切削参数优化；使用 UG/NX , Esprit或 Mastercam 完成 CAM 编程与加工仿真；跟进样件试制与首件验证，解决试制阶段尺寸偏差、加工变形、表面粗糙度不良、毛刺等技术问题。

·       Organize multi‑round trial production verification, collect and analyze machining process data, identify process fluctuation and yield bottlenecks. Complete the compilation of full‑set process documents including Work Instruction and SOPs, and realize smooth design and process transfer.

组织多轮试产验证，收集分析加工工艺数据，识别工艺波动与良率瓶颈；完成SOP 作业指导书等工艺文件编制，实现设计与工艺平稳移交。

·       Design and select specialized CNC tooling and fixtures according to product structural characteristics and precision requirements. Follow up fixture processing, assembly and on‑site debugging verification. Continuously optimize clamping schemes and positioning methods, reduce machining deformation, improve product consistency and production efficiency, and meet the high‑precision manufacturing standards of medical device parts.

根据产品结构特点与精度要求完成 CNC 专用工装夹具的设计与选型；跟进夹具加工、装配及现场调试验证；持续优化装夹方案与定位方式，降低加工变形，提升产品一致性与生产效率，满足医疗器械零部件高精度制造标准。

·       Cooperate with the quality team to complete equipment IQ/OQ/PQ verification and production process validation. Define critical process parameters (CPP) and critical quality attributes (CQA) of core machining processes. Ensure all process documents, process changes and production operations fully comply with ISO13485 medical device quality management system specifications.

配合质量团队完成设备 IQ/OQ/PQ 验证及生产工艺验证；定义核心加工过程的关键工艺参数（CPP）与关键质量属性（CQA）；保证所有工艺文件、工艺变更及生产作业完全符合 ISO13485 医疗器械质量管理体系规范。

·       Communicate and collaborate with R&D, quality, production and purchasing teams to close‑loop resolve all manufacturing technical problems in new product development. Adopt A3, 8D and other quality analysis tools to analyze defective products and process abnormalities. Establish and improve the CNC process database including medical material cutting parameters, standard tool schemes and typical problem solutions. Promote process cost reduction, cycle time optimization and yield improvement.

与研发、质量、生产、采购团队沟通协作，闭环解决新产品开发中的各类制造技术问题；运用 A3、8D 等质量分析工具对不良品、工艺异常开展分析；搭建并完善包含医用材料切削参数、标准刀具方案、典型问题解决方案的 CNC 工艺数据库，推动工艺降本、节拍优化及良率提升。

·       Provide professional process training for production teams after new products are transferred to mass production. Continuously track and solve process abnormalities in the early stage of mass production, stabilize the process window, and assist the production line to complete production ramp‑up and capacity stabilization goals.

新产品移交量产后，为生产团队提供专业工艺培训；持续跟踪解决量产初期工艺异常，稳定工艺窗口，协助产线完成产能爬坡与产能稳定目标

分析问题和识别、提供有效的方案

·       Continuously fully comply will all GMP standard requirements.

完全遵守GMP标准的要求。

·       All other duties as assigned

完成上级安排的其它工作

SUPERVISORY RESPONSIBILITIES管理职责:

 N/A

REQUIRED SKILL SET岗位技能：

• He/She is expert in one or more than one core competencies.

他/她是专家在一个或多个核心竞争力。

• He/She has very good oral and written communication skills.
• 他/她有很好的口头和书面沟通技巧。
• He/She has very good presentation skills.

他/她有很好的表达能力

• He/She is professional in technical writing (e.g. process validation protocols, technical reports)

他/她有专业技术写作(如工艺验证协议,技术报告)

• He/She is professional in problem solving skills and has a passion to improve, he is creating new ideas help to improve.

他/她有专业的解决问题的能力和热情,

• He/She is self-directed,proactive

他/她是自主的,积极主动

• He/She is a master in engineering concepts, tools and processes.

他/她是一个专家在工程概念、工具和流程。

• He/She has strong mentoring and people development skills.

他/她有很强的指导和开发技能。

• He/She has strong PC and appropriate application skills (office and engineering software).

他／她有很强的办公软件及工程软件使用能力

·       Must be able to analyse and correct products and process issues using independent judgment.

能独立分析纠正产品过程问题

·       Excellent analytical skills.

较强的分析能力

·       English reading and writing is a must.　

英语读与写能力

RELEVANT EXPERIENCE

经验要求：

·       Minimum 3‑years of working experience in CNC machining. Prior experience in processing stainless steel, titanium alloy, medical‑grade plastics and PEEK is preferred.

3 年以上CNC机械加工相关工作经验，有不锈钢，钛合金，医用塑料，PEEK 加工经验优先.

·       Experience in medical device industry is preferred.

医疗行业优先

·       Familiar with GD&T standards and the complete NPI process from prototype to mass production

熟悉 GD&T 标准以及从样件到量产完整 NPI 流程

EDUCATION

教育背景：

·       College degree or above, major in mechanical technology, material processing or other related disciplines.

大专学历及以上，机械工艺，材料加工等相关专业

·       ISO 13485/Quality Systems Expertise and Application

了解ISO13485质量体系

Travel Percentage: None