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.