Job Responsibility:
- Lead manufacturing and supply chain design transfer for new flow instruments, subsystems, software-enabled workflows, reagents, and related consumables from feasibility through production release.
- Represent Operations and Supply Chain in cross-functional core teams; translate application, customer, and manufacturing needs into clear product, system, software, serviceability, and manufacturability requirements.
- Own factory NPI deliverables and integrated execution plans, including supply chain feasibility and planning, build readiness reviews, pre-production order reviews, manufacturing readiness reviews, and design transfer reviews.
- Develop and release robust manufacturing and system-test processes, work instructions, standard work, line or cell layouts, utility and network requirements, market configurations, MBOMs, and DMR/DHR content in accordance with approved specifications.
- Lead process risk assessment and validation activities, including pFMEA, test method validation, fixture and equipment verification or qualification, and process validation such as IQ, OQ, PQ, and PPQ, as applicable.
- Design, optimize, and sustain instrument performance and system-level testing, calibration, reagent or chemical preparation and control, and associated shop-floor workflows to improve quality, stability, cycle time, and operating efficiency.
- Lead prototype and pre-production build support, structured problem solving, issue tracking, root-cause analysis, and corrective actions in close partnership with R&D, Quality, Service, Materials & Planning, Sourcing, and Production.
- Drive Design for Manufacturing, Assembly, Service, and Test reviews; facilitate SDR and related engineering events; define actionable improvements and ensure timely closure of design and process risks.
- Develop standard cost models and manufacturing inputs for capital, labor, material, capacity, and resource planning; identify cost, quality, delivery, and capacity risks and recommend mitigation plans.
- Train and coach production associates and engineering partners, support production ramp and early-life stabilization, transfer knowledge across sites.
- Provide subject-matter expertise for assigned processes and products, including specialized quality-control or value-assignment processes, while balancing priorities across multiple NPI programs.
- Contributes towards continuously improving global standard work and application of NPI design transfer of BEC LS products.
Qualification:
Functional Knowledge ：
- Requires depth and/or breadth of expertise in own specialized discipline or field.
- Strong knowledge of design control and quality management systems, particularly design transfer, design change, production and process control and purchasing control, preferably life-science, medical-device, or IVD products.
- Hands-on expertise in system and instrument performance testing, calibration, test-method development and validation, fixture or equipment qualification, and manufacturing process validation.
- Working knowledge of flow cytometry applications, reagent or chemical handling, software-enabled manufacturing workflows, and data-driven acceptance testing is strongly preferred.
- Proficiency in DFx, pFMEA, root-cause analysis, statistical methods, Lean manufacturing, Six Sigma or variation reduction, and structured problem-solving tools.
Business Expertise:
- Interprets internal/external business challenges and recommends best practices to improve products, processes or services
- Understands how product requirements, regulatory expectations, supply chain decisions, factory capability, cost, quality, delivery, and capacity interact across the product lifecycle.
- Applies project-management practices to scope, schedule, resources, dependencies, risk, cost modeling, and capital planning; converts business challenges into practical execution plans.
Leadership:
- May lead functional teams or projects with moderate resource requirements, risk, and/or complexity.
- Leads cross-functional workstreams or projects of moderate to high complexity without direct authority and is capable of serving as the Operations or Supply Chain Design Transfer Lead.
- Sets clear priorities, drives accountability and timely decisions, coaches less-experienced engineers, and escalates risks with concise, fact-based recommendations.
Problem Solving:
- Leads others to solve complex problems; uses sophisticated analytical thought to exercise judgement and identify innovative solutions.
- Diagnoses system-level and module-level failures with R&D and other partners; identifies root causes, validates solutions, and prevents recurrence while balancing quality, delivery, and cost.
Impact:
- Impacts the achievement of customer, operational, project or service objectives; work is guided by functional policies.
- Directly influences achievement of project milestones, production readiness, product quality, supply continuity, standard cost, capacity, and on-time delivery objectives.
- Work is performed with substantial autonomy within functional policies; decisions and recommendations may affect multiple functions, sites, and product programs.
Interpersonal Skills:
- Communicates difficult concepts and negotiates with others to adopt a different point of view.
- Communicates complex technical and business concepts clearly in English and Chinese with engineering, operations, quality, supply chain, and leadership stakeholders across regions.
- Facilitates reviews, aligns stakeholders with different priorities, and uses influence and negotiation to reach fact-based decisions and commitments.
Education & Experience:
- Major in mechanical, electrical, automation, biomedical, manufacturing, industrial, chemical engineering, or a related technical field.
- Bachelor’s degree in field with 9+ years exp. OR
- Master’s degree in field with 7+ years exp. OR
- Doctoral degree in field with 4+ years exp.
- Experience leading NPI design transfer for complex systems/instruments and coordinating global, cross-functional teams is required; medical-device or IVD experience is preferred.
- Project Management, Lean, Six Sigma, or quality-related certification is preferred but not required.
岗位职责:
- 主导新型流式细胞仪器、子系统、基于软件的工作流、试剂及相关耗材从可行性阶段到生产放行的制造与供应链设计转移 。
- 在跨职能核心团队中代表运营与供应链，将应用、客户和制造需求转化为清晰的产品、系统、软件、可维护性及可制造性要求。
- 负责工厂端新产品导入交付物及整合执行计划，包括供应链可行性与规划、搭建准备评审、预生产订单评审、投产准备评审和设计转移评审。
- 根据批准的规格，开发并发布稳健的制造与系统测试流程、作业指导书、标准作业、产线或单元布局、公用设施和网络要求、物料配置、制造BOM以及DMR/DHR相关内容 。
- 主导过程风险评估和验证活动，包括pFMEA、测试方法验证、工装和设备验证或确认，以及适用的IQ、OQ、PQ和PPQ等过程验证。
- 设计、优化并维护仪器性能及系统级测试、校准、试剂或化学品制备与管控及相关车间流程，以提升质量、稳定性、周期时间和运营效率 。
- 与研发、质量、服务、物料和计划、采购和生产团队紧密合作，主导样机及预生产构建支持、结构化问题解决、问题跟踪、根因分析和纠正措施。
- 推动面向制造、装配、服务和测试的设计评审，组织SDR及相关工程活动，制定可执行的改进措施，并确保设计及过程风险按时关闭。
- 建立标准成本模型，并提供资本、人工、物料、产能和资源规划所需的制造输入；识别成本、质量、交付和产能风险并提出缓解方案。
- 培训并辅导生产员工及工程合作伙伴，支持生产爬坡和早期稳定，推动跨工厂知识转移。
- 为指定的流程和产品提供专业支持，包括特定质量控制或目标值赋值流程，并在多个NPI项目之间合理平衡优先级。
- 致力于持续改进全球标准作业并应用到贝克曼生命科学产品的新产品导入设计转移过程中。
任职资格:
职能知识：
- 要求掌握自己专业学科或领域中的具有深度和/或广度的专业知识。
- 具备系统及仪器性能测试、校准、测试方法开发与验证、工装或设备确认以及制造过程验证的实践经验。
- 具备流式细胞术应用、试剂或化学品操作、软件赋能制造流程及数据驱动验收测试相关知识的实经验者将优先考虑。
- 熟练掌握DFx、pFMEA、根因分析、统计方法、精益制造、六西格玛或变差降低及结构化问题解决工具。
业务专业知识:
- 诠释内部/外部业务挑战并推荐最佳实践以改善产品、流程或服务。
- 理解产品要求、法规预期、供应链决策、工厂能力、成本、质量、交付和产能在产品生命周期中的相互影响。
- 运用项目管理方法管理范围、进度、资源、依赖关系、风险、成本模型和资本规划，并将业务挑战转化为可执行计划。
领导力:
- 能够领导职能团队或带有适度资源要求、风险和/或复杂性的项目。
- 能够在无直接汇报关系的情况下领导中高复杂度跨职能工作流或项目，并可担任运营或供应链设计转移负责人 。
- 明确优先级，推动责任落实和及时决策，辅导经验较少的工程师，并基于事实以简洁方式升级风险和提出建议。
解决问题:
- 领导他人解决复杂问题；使用精细分析思考作出判断并确定创新解决方案。
- 与研发及其他合作伙伴共同诊断系统级和模块级故障，识别根因、验证解决方案并防止复发，同时平衡质量、交付和成本。
影响:
- 对客户的成果、经营活动、项目或服务活动产生影响；工作由职能政策予以指导。
- 直接影响项目里程碑、生产准备度、产品质量、供应连续性、标准成本、产能和按时交付目标的实现。
- 在职能政策框架内具有较高自主性，其决策和建议可能影响多个职能、工厂及产品项目。
人际交往技巧:
- 沟通困难概念并与他人协商以采用不同观点。
- 能够使用中英文向跨区域的工程、运营、质量、供应链及管理层相关方清晰沟通复杂技术和业务概念。
- 组织评审，协调不同优先级的相关方，并通过影响力和协商推动基于事实的决策与承诺。
学历与经验:
- 机械、电气、自动化、生物医学、制造、工业、化学工程或相关技术专业
- 本科学历并且有9年以上相关经验， 或者
- 硕士学历并且有7年以上相关经验 ，或者
- 博士学历并且有4年以上相关经验
- 要求具备复杂系统或仪器NPI设计转移领导经验及全球跨职能团队协调经验；具有医疗器械或体外诊断行业经验者优先。
- 项目管理、精益、六西格玛或质量相关认证优先，但非必需。
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.