Summarize of the Role角色总结
 Lead new product transfer and integration. 负责新产品转移、导入。
 Support continuous improvement in site level. 支持工厂持续改善活动。
Job Description and Responsibility岗位概述以及主要职责
 Lead new product transfer and integration. 负责新产品转移、导入。
1. Lead local project team to transfer the medical device (machine & consumable) from manufacturing site oversea to local manufacturing site.
o Lead project team to transfer and localize technical documents, including drawing, Inspection procedure, Operation procedure, Working instruction etc.
o Lead project team to build the related facility and utility according to the requirement of production process and regulatory.
o Coordinate cross functions to prepare qualification and validation documents and execute accordingly.
o Coordinate cross functions to set up the supply chain of raw material, source and purchase materials, consumables and equipment according to the validate specifications or URSs.
o Recruit manufacturing team, transfer the production process and operation skill to manufacturing, ensure operation training and qualification are conducted on time.
o Lead team to execute the testing and qualification according to the approved testing and qualification plan, under the guidance from Manufacturing Engineering.
o Coordinate project team to set up the new products’ master data, BOM, routings etc. in SAP.
o Support QA to ensure the QMS are ready and comply with regulation.
o Support RA team for submission preparation if necessary.
o Facilitate cross functions to review the milestones of project.
o Identify the risk and issue, thing broadly and act as a problem solver.
2. As a project manager to cooperate with R&D and Engineering, Quality, Procurement, RA, Finance, Marketing, Sales to ensure the project moving with defined timeline and hitting the planned milestones.
3. Build the bridge between China Manufacturing sites and global manufacturing sites, host and facilitate the review meeting or technical discussion between sites in a regular basis.
4. Actively contact with Sales, Marketing, RA to ensure the voice from market and regulations are considered in the new product integration.
 Support continuous improvement activities in stie level. 支持协调工厂的持续改善活动。
1. Support continuous improvement projects. Drive team to achieve site annual productivity improvement target.
2. Act as SME of lean-six sigma, to provide professional support to the team.
3. Support other improvement activities in manufacturing and warehouse
On-job requirement任职资格
 Professional Requirement
o 5-8 years working experience in top medical device companies or pharmaceutical companies with proven success project experience in new product transfer and integration.
o Over 3 years project management experience, PMP is preferred.
o Solid experience in design & development or manufacturing scale up of medical device.
o Experience of lean- six sigma with proven success story is preferred.
o Fluent in English (Speak, listen and Wiring)
o Experience on SAP, SolidWorks or Power BI is preferred.
 Soft skill
o Be able to well manage the project under pressure.
o Data driven; results driven with flexible communication skill.
o Positive and open mind, well prioritize with multiple activities.
o Good presentation skill.
 Education
1. Bachelor in Process engineering, Mechanical engineering etc.