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苏州市, 江苏省, 中国
Onsite
Position Summary:
This position plays a key role in the Manufacturing Engineering team, with responsibility for CT DMS detector manufacturing process sustaining, process control, yield and quality improvement, new product introduction, and manufacturing transfer. The role is expected to work closely with Production, Quality, Equipment, R&D, Supply Chain and suppliers to ensure robust, compliant, efficient and scalable detector manufacturing processes.
该职位在制造工程团队中承担关键职责，负责CT DMS（探测器）制造工艺维持、工艺控制、良率与质量改进、新产品导入及制造转移相关工作。该岗位需与生产、质量、设备、研发、供应链及供应商紧密协作，确保探测器制造工艺稳定、合规、高效并具备可扩展性。
Job Responsibilities:
Production Line Sustaining / 生产线维持
• Maintain and continuously improve DMR, work instructions, process flow, routing, production records, training materials and other manufacturing documentation according to ECR, PPC and ECO requirements.
• Provide work instruction training and technical training to production teams, ensuring clear understanding of critical process parameters, quality controls and escalation criteria.
• Handle daily production issues and nonconformities, conduct root cause analysis, and work with cross-functional teams to define containment, corrective and preventive actions to minimize line interruption.
• Support Equipment team on installation, verification, calibration, maintenance and repair of production equipment, tooling, fixtures and test stations.
• Support change control execution in production and introduce new product, new process, new material or new component with proper readiness assessment and risk control.
Process Control, Yield and Quality Improvement / 工艺控制、良率与质量改进
• Define, maintain and improve key process parameters, inspection points, acceptance criteria and control methods for CT DMS detector manufacturing processes.
• Use data analysis, structured problem solving and statistical methods to improve first-pass yield, process capability, quality performance and production stability.
• Evaluate design change, supplier change, material change and process change requests to identify potential impact on product quality, manufacturability, reliability and compliance.
• Support MQ and SQE on incoming failure analysis, process failure investigation, customer complaint analysis and DEFOA activities.
• Work with Quality team to fulfill QMS requirements and support internal and external audits, including TUV, NMPA, FDA and other applicable regulatory audits.
NPI, Manufacturing Transfer and Industrialization / 新产品导入、制造转移与工业化
• Act as a key Manufacturing Engineering stakeholder in CT DMS detector NPI, manufacturing transfer, localization and industrialization projects.
• Lead or support process validation, pilot build, production ramp-up, line readiness review, risk assessment and handover from project phase to stable production.
• Translate design and process requirements into manufacturable solutions, including process flow, tooling and fixture requirements, test requirements, training package and production control plan.
• Collaborate with R&D, Quality, Procurement, Production and suppliers to resolve manufacturability issues and improve design-for-manufacturing outcomes.
Lean, Automation and Cost Reduction / 精益、自动化与成本降低
• Continuously improve productivity through standardized work, line balancing, process simplification, mistakeproofing, automation and digital manufacturing initiatives.
• Optimize manufacturing processes and eliminate waste by applying lean methods and tools.
• Organize and lead kaizen activities and improvement projects that support factory Hoshin priorities, operational excellence and manufacturing risk reduction.
New Equipment, Tooling and Fixture Introduction / 新设备、工装夹具引入与改进
• Identify opportunities to improve existing equipment, tooling, fixtures and test stations, or define requirements for new equipment and process capability needs.
• Define user requirements, qualification requirements, calibration requirements and maintenance strategy for new equipment, tooling and fixtures.
• Work with R&D, Equipment team and suppliers to complete equipment introduction, verification, qualification and release-to-production activities.
Minimum required Education:
• Bachelor’s degree or above in mechanical engineering, electronics, electrical engineering, automation, materials, industrial engineering or other related technical disciplines.
Minimum required Experience:
• 5+ years of manufacturing engineering, process engineering, industrialization or related engineering experience in a regulated or high-reliability manufacturing environment.
• Direct experience in CT detector, DMS detector manufacturing processes, detector module assembly, calibration, testing, alignment, bonding, cleaning, ESD control or other precision manufacturing processes is strongly preferred.
• Experience in DMS detector product development, R&D engineering, process development, product industrialization or manufacturing transfer is highly preferred.
• Experience with X-ray imaging components, scintillator, photodiode, electronic module assembly, semiconductor or optoelectronic manufacturing is preferred.
• Experience in production line sustaining, process validation, NPI, manufacturing transfer, equipment introduction, yield improvement and quality improvement.
• Experience in medical device, precision assembly, electronic module, detector, X-ray/CT component, semiconductor, optoelectronics or other high-reliability manufacturing environment is preferred.
• Experience in high-mix, low-volume or multi-variety manufacturing environment is preferred.
Preferred Skills:
• Solid manufacturing fundamentals and strong hands-on capability in process setup, troubleshooting, documentation, training and continuous improvement.
• Good understanding of regulated manufacturing requirements, including DMR, WI, ECO execution, change control, process validation and risk management.
• Strong data analytics, problem-solving and root cause analysis capability; familiar with tools such as 5 Why, fishbone diagram, Pareto, SPC, DOE, FMEA, control plan and 8D.
• Familiarity with ISO 13485, QSR, MDR, CGMP, MDSAP and applicable medical device QMS requirements is preferred.
• Strong project management capability and ability to work effectively with cross-functional teams including Production, Quality, R&D, Equipment, Procurement and suppliers.
• Lean manufacturing mindset; experience in standardized work, line balance, kaizen, automation or digital manufacturing is preferred.
• Good teamwork, communication and stakeholder management skills, with the ability to drive actions and deliver results across functions.
• Good English reading and writing capability; able to communicate technical topics in English when needed.
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