I.       General Summary & Overall Challenges
This position will be placed in Manufacturing & Operations organization and responsible for immunoassay instrument production in the technical support team. Three primary challenges will be provided to this position:

1.    The ability to support the production lines and keeping them running at all times in terms of right quality and on time delivery

2.    The ability to master the process of assembly/testing and well handle instrument products assembly/testing troubleshooting case.

3.     The ability to work close with QA, Sourcing, Purchasing, R&D and NPI departments to obtain a smooth integration.

This position will give you an excellent opportunity to gain valuable experience in the day-to-day challenges, production optimization and Lean.
The work includes daily management as well as IE and manufacturing technical related improvement projects within the department.

II.       Key Responsibilities
 
Responsibilities & Measure of performance
·        Technical support to the production to ensure on time delivery.
→
D: Sustain on time delivery
Q: Improve Quality :External PPM and first pass yield rate
·        Systematic problem solving of quality issues.
→
Q: Improve Quality
P: Increase productivity
·        Handling post-engineering and product maintenance issues.
→
D: Sustain on time delivery
·        Training to production line /Documentation/Validation related to responsible products
→
D: Sustain on time delivery
Q: Regulatory compliance

·        Participate in DBS/Kaizen activities to improve equipment and processes.
→
Q: Improve Quality
P: Increase productivity
 
 
III.       Requirements for this position (“What” the candidate can do)
 
·        Bachelor’s degree or above in Mechanical Engineering/ Electrical Engineering/Mechatronics or related filed
·        Minimum 5 years of experience in medical device manufacturing or similar industry
·        Production management experience, to maintain daily product assembly or testing process conducted operated smoothly as planned
·        Technical knowledge of schematic and technical drawings
·        Hands-on experience with tools and equipment in assembly or testing process, familiar with the tools developing and optimizing process for fixture, gauge etc.
·        Understanding production BOM, familiar with engineering change process
·        Good documentation capability of writing the assembly or testing WI, SOP etc.
·        Strong analytical, problem-solving and presentation skills
·        Practical experience with validating processes in a regulated environment
·        Good knowledge of LEAN tools for operation improvement, e.g. DM, SW, PSP, VSM and 3P etc.
·        Good data analysis skills, familiar with statistical analysis tools like MiniTab, SAS JMP etc.
·        Practical experience of application of AutoCAD or SolidWorks
·        Good knowledge of medical device industry related standards like ISO 13485 will be preferred
·        Experience of working in complex organization/projects with many peers
·        Creative, open minded and hard-working with good teamwork ethic spirits always exhibited in daily work
·        Fluent English skills, both in oral and written
·        Proficient skills of MS Office Excel, Word, PowerPoint, Visio etc.
·        Accept short-term business travel when needed

其他信息

行业要求：全部行业