越南-某大型电子制造企业 招聘医疗EPM

职位描述：

1. 项目全周期管理

- 负责医疗器械代工项目从立项到交付的全流程管控，依据客户需求制定项目计划（含进度、成本、质量目标），并落地执行；

- 跟踪项目节点（如设计评审、样品确认、量产爬坡），及时识别进度延误、成本超支等风险，制定应对方案并推动解决。

Responsible for end-to-end management of medical device OEM projects from initiation to delivery. Develop and execute comprehensive project plans (including schedule, cost, and quality targets) based on client requirements.

Monitor key project milestones (e.g., design reviews, sample approval, production ramp-up). Proactively identify risks such as schedule delays or budget overruns, formulate mitigation strategies, and drive their resolution.

2. 跨部门与客户协同

- 对接内部研发、生产、质量、采购等团队，明确各环节责任与交付标准，确保资源高效调配，保障项目按计划推进；

- 作为客户对接第一责任人，定期同步项目进展，收集客户反馈，协调解决需求变更、技术疑问等问题，维护客户合作关系。

Liaise with internal teams (R&D, Production, Quality, Sourcing) to define responsibilities and deliverables at each stage, ensuring efficient resource deployment and adherence to the project timeline.

Act as the primary point of contact for clients, providing regular project updates, gathering feedback, and addressing issues such as change requests and technical inquiries to maintain strong customer relationships.

3. 合规与质量把控

- 确保项目全流程符合医疗器械行业法规及客户质量要求，参与设计评审、风险评估及质量问题整改；

- 主导项目验收工作，整理项目文档（如BOM、工艺文件、检验报告），归档并移交相关部门。

Ensure full compliance with medical device industry regulations and customer quality requirements throughout the project lifecycle. Participate in design reviews, risk assessments, and quality issue resolution activities.

Lead project closure and handover activities, including consolidation of project documentation (e.g., BOM, process files, inspection reports) for archiving and transfer to relevant departments.

4. 项目复盘与优化

- 项目结束后组织复盘，总结经验教训，输出项目复盘报告；

- 推动项目管理流程优化，提出改进建议（如工具升级、流程简化），提升团队项目管理效率。

Organize post-project reviews to summarize lessons learned and generate post-mortem reports.

Drive continuous improvement of project management processes by proposing enhancements (e.g., tool upgrades, process simplifications) to increase team efficiency.

任职资格：

1. 学历与专业：本科及以上学历，医疗器械、生物医学工程、机械工程、项目管理等相关专业；持有PMP（项目管理专业人士）认证者优先。

Bachelor's degree or higher. Major in Medical Devices, Biomedical Engineering, Mechanical Engineering, Project Management, or a related field. PMP (Project Management Professional) certification is preferred.

2. 工作经验：3年及以上医疗器械代工（OEM/ODM）项目管理经验，熟悉医疗器械从设计开发、样品制作到量产交付的全流程；有二类及以上医疗器械项目操盘&CGM经验者优先。

Minimum 3 years of project management experience in medical device OEM/ODM.Proficient in the entire product lifecycle from design development, prototyping to mass production and delivery.Experience in managing Class II (or above) medical device projects and with Continuous Glucose Monitoring (CGM) products is highly preferred.

3. 专业能力：

- 掌握医疗器械行业法规（如NMPA、FDA、CE认证要求），能确保项目合规推进；

Familiar with medical device industry regulations (e.g., NMPA, FDA, CE Marking requirements) and capable of ensuring project compliance throughout its lifecycle.

- 具备项目计划制定、成本管控、进度跟踪能力，可使用Project工具高效管理项目；

Proven ability to develop project plans, control costs, and track progress. Proficient in using Microsoft Project for efficient project management.

- 擅长跨部门协同（研发、生产、采购、质量）及客户沟通，能协调资源解决项目瓶颈问题。

Good at cross-functional collaboration (with R&D, Production, Sourcing, and Quality) and customer communication. Able to coordinate resources to resolve project bottlenecks.

4. 语言能力： 英文听说读写熟练

Fluent in English, with strong communication skills in all modes (verbal and written).

5. 软技能：具备较强的抗压能力、问题解决能力及风险预判意识，逻辑清晰，沟通表达及谈判能力优秀。

A resilient problem-solver who thrives under pressure, with strong risk anticipation, logical thinking, and exceptional communication and negotiation skills.