Role and Responsibilities:

1. Responsibly manage and lead the China product development group by providing directions, priorities and working collaboratively with Stakeholders in LoopLab Chicago to meet strategic goals

2. Provide Leadership for the China Office tech team to develop new prototypes, an internal office project tracking system and a mold and jig development and qualification process

3. Provide scientific and engineering technical support for LoopLab US product development and research group objectives to include design review, DFM, DFT, DFC, Prototypes, First article and pre-production runs , through qualification of the product and manufacturing process.

4. Overseen the transfer of new product specification and Engineering change orders to our contract manufacturers and ensure accurate and complete implementation

5. Project management, including defining scope planning, developing schedule, .allocation, risk assessment, execution' controlling' monitoring, transition project from product development to commercialisation

6. Qualify factories, suppliers, sub-supplier’s materials and facilitates including hazards analysis and critical control point HACCP assessments.

7. Serve as the focal point interface between RD&E functions ' local (China) contract manufacturers (CMOS) and component suppliers to produce new materials and prototypes

8. Troubleshoot new production process or problems with prototype designs

9. Develop and implement manufacturing process improvement plan to improve productivity by increasing product throughput

Job qualification:

• Bachelor's degree in Electrical or Mechanical Engineering or related field
• 5+ years experience in New Product Development or R&D Organisation
• 3+ years in leading and providing directions to a team of direct reports.
• Experience in application of requirements for medical device development including but not limited to software-as-medical device, design controls (CFR 820, ISO 13485) and risk management (ISO 14971)
• Experience in applying production and process controls including process validation, process control plans and statistical process control
• Solid knowledge of engineering fundamentals and proven ability to apply this knowledge to new product development and manufacturing
• Excellent organizational and Project Management skills.
• Strong communication skills in English both verbal and written

上班地址：科技园北区朗山一路6号意中利科技园1栋5楼/2栋3楼