Key Responsibilities / 主要职责
1. Project leadership & coordination
• Act as primary mould engineering representative in cross-functional project teams (PM, QA, Process, Production). Track schedules and drive on-time FOT/SAT and tooling transfer.
• 作为跨部门项目组的模具技术负责人，协调项目进度，推动试模（FOT）/生产验证（SAT）及模具移转按计划完成。
2. Design for Manufacturability & Design Review
• Conduct DPRs (design producibility reviews), review/approve mould designs, provide improvement proposals (e.g., parting, cooling, gating, draft, material saving, cosmetics). Use CAD/CAM outputs to validate manufacturability.
• 组织产品可制造性评审，审核并批准模具设计，提出优化建议（分型面、冷却、浇口、拔模、材料节约、外观等），并基于CAD/CAM结果验证可制造性。
3. Tool manufacture follow-up & supplier management
• Create and maintain tooling schedules, perform regular follow-ups with internal toolroom and external toolmakers, ensure tooling manufacturing quality, tolerance control and on-time delivery.
• 制定并维护模具制造进度表，定期跟进内外协模具厂，确保制造质量、公差控制及交付期满足要求。
4. Mould verification, trial & problem resolution
• Lead first-off trials (FOT), production acceptance tests (SAT) and validation activities (IQ/OQ/PQ as applicable). Diagnose molding issues (flash, short shots, warpage, blemishes) and implement corrective actions until customer acceptance.
• 主导试模（FOT）、生产接收（SAT）及验证工作（IQ/OQ/PQ），诊断注塑问题并推动纠正措施，直至客户接受。
5. Tool transfer, handover & maintenance planning
• Manage tooling transfer and acceptance processes, complete tooling identification and handover documentation, and generate preventive maintenance plans with shop/maintenance teams.
• 负责模具移转接收与交接，填写模具识别及交接文件，并与模房/维护组制定预防性维护计划。
6. Change control & lifecycle management
• Initiate/evaluate tooling changes, assess technical/cost/schedule impacts, obtain approvals (including written customer approval if changes affect form/function), and manage lifecycle improvements and repairs.
• 发起或评估模具变更，评估技术/成本/进度影响；若影响产品外观/功能须取得客户书面确认；负责模具全生命周期的改进与维修管理。
7. Documentation & quality records
• Ensure complete documentation: 3D/2D product drawings, DPR minutes, tooling spec, trial reports, inspection records and QA dossiers in accordance with company QMS and regulatory requirements (e.g., ISO13485).
• 确保文档完整：产品3D/2D图、DPR记录、模具规格、试模/检验记录及QA文件，符合公司质量管理体系和法规要求（如ISO13485）。
8. Continuous improvement & risk management
• Apply FMEA and other risk tools for mould/process risks; propose reliability and productivity improvements (cycle time, scrap reduction, tool life extension).
• 应用FMEA等风险工具识别模具/工艺风险，提出可靠性和效率改进方案（缩短周期、降低报废、延长模具寿命）。
Qualifications / 任职资格
• Education: Bachelor’s degree or above in Mechanical Engineering, Tooling, Plastics Engineering or related field.
• 学历：机械工程、模具、塑料工程或相关专业本科及以上。
• Experience: Minimum 5 years’ hands-on experience in mould engineering for precision injection; experience in medical device moulds or high-cosmetic/critical parts preferred. Full lifecycle experience from development to mass production is required.
• 工作经验：至少5年精密注塑模具工程经验；有医疗器械模具或高外观/关键件经验者优先。需具备从开发到量产的完整项目经验。
• Language: Proficient in English (spoken and written) for technical communication with customers and suppliers. 
• 语言：具备良好的英语读写与口语能力以应对客户/供应商沟通。
Technical Skills & Competencies / 技能与能力
• CAD/CAM: Proficient with 3D/2D CAD ( NX/UG, Creo) and able to review tooling drawings and tolerances.
• 模具设计软件：熟练掌握3D/2D CAD（UG/ NX, Creo），能审核模具图纸与公差。
• Moldflow & DFM: Experience with moldflow analysis and design-for-manufacturability assessments.
• 模流与制造性评估：具备模流分析与可制造性评审经验。
• Quality & Regulatory: Familiar with ISO13485, GMP, (risk management) and relevant inspection standards; experience with FMEA and PPAP/VDA processes advantageous.
• 质量与法规：熟悉ISO13485、GMP；熟练应用FMEA，了解PPAP/VDA流程者优先。
• Metrology & Validation: Able to define inspection plans, interpret measurement data and lead DQ/IQ/OQ activities.
• 计量与验证：能制定检验计划、解读测量数据并主导IQ/OQ/PQ活动。
• Strong communication, supplier management, problem-solving, project management and ability to work under pressure.
• 具备良好沟通、供应商管理、问题分析与项目推动能力，抗压能力强。