About the Company：
A foreign company
Responsibilities：
1、Act as the manufacturing technical lead for new product development projects, supporting process development and validation activities as well as product launch and build planning in production.
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2、Support the conversion of small-scale processes into commercially viable operations including documentation, equipment, and process development.
3、Evaluate, implement, and monitor processes and equipment for the manufacture of medical products.
4、Lead continuous improvement programs by implementing measures to improve production methods, equipment performance, and quality of product. Conduct statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
5、Function as the manufacturing lead for process validation and process monitoring.
6、Work with procurement team to allocate equipment to site with installation, create the work instructions as well as set up the maintenance plan.
7、Design and sourcing for applicable fixtures.
8、Author & review IQ, OQ, and PQ protocols in addition to performing process validations
9、Provide key technical and project management support in capital projects
10、Utilize Process Failure Mode and Effects Analysis (PFMEA) and Design Of Experiments to analyze manufacturing processes.
11、Test protocol generation, execution, and reporting.
12、Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra’s procedures and statutory requirements (NMPA and ISO).
13、Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct Non-Conformance (NC) Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA support).
Requirements：
1、Bachelor (> 5 years experience) or Master (> 2 years experience) equivalent in Polymer, Chemistry, or Material Science. The analytical ability is required.
2、Possess experience in two or more of the following technical areas is plus: polymer chemistry, polymer physics, polymer rheology, polymer adhesion, polymer formulation, polymer molding, or polymer characterization.
3、Proven communication skills and ability to perform within a cross-functional team environment.
4、Ability to drive change initiatives.
5、Interpersonal and communication skills.
