Key Responsibilities:
Monitor and analyze industry trends and market demands to identify new application opportunities; develop R&D plans aligned with company capabilities.
Lead or support the development and optimization of catheter materials and process designs; assess material compatibility with catheter manufacturing processes.
Design catheter components and associated tooling—including extrusion dies, injection molds, balloon molds, and fixtures—using SolidWorks.
Manage the non-conformance process by driving NC, CAPA, and SCAR activities, including root cause analysis, verification, validation, and implementation of corrective actions.
Develop and revise technical documentation such as SOPs, BOMs, Travelers, EFTs (Work Orders), MPIs, NCOs, DHRs, DHFs, FMEAs, Control Plans, and other quality or manufacturing documents.
Plan and execute validation activities (IQ/OQ/PQ) for processing equipment and medical device components in compliance with FDA regulations.
Perform process verification (OQ/PQ) for the production of extruded components and subassemblies.
Analyze data using Minitab or JMP to identify trends, troubleshoot issues, and implement cost improvement projects (CIP) for enhanced efficiency and savings.
Manage multiple concurrent projects and lead cross-functional, multi-site teams in the development and optimization of catheter processing and manufacturing.
Provide technical support for post-launch production processes and drive continuous improvement initiatives for new product introductions.
Define and maintain technical specifications for products, raw materials, and testing methodologies.
Stay informed on the latest advancements in polymers, medical device manufacturing, and process engineering; contribute to building the company’s R&D knowledge base.
Collaborate closely with R&D, Quality, Production, and Supply Chain teams to ensure material and process strategies support product development goals.
Ensure compliance with GMP and ISO 13485 standards throughout all activities.
1. Track and analyze industry products and market demands to identify application trends; formulate product R&D plans aligned with the company's capabilities.
2. Lead or participate in the development and modification of new catheter materials and process design; evaluate material compatibility with catheter manufacturing processes.. Provide post-mass-production process technical support and drive continuous process improvement for new products.
. Establish product technical specifications, raw material specifications, testing methods, and other technical documentation.
. Proactively monitor cutting-edge developments within the technical field and accumulate R&D resources.
. Collaborate with other departments to ensure material strategies align with product development objectives.
Qualifications:
1. Master's degree or higher in Materials, Chemical Engineering, Polymer Science, or a related discipline.
2. Minimum 2 years of experience in a similar role preferred; experience in the medical device materials industry is highly advantageous.
3. Proficient in polymer material modification and material testing techniques; knowledge of material processing equipment required, relevant hands-on experience preferred.
4. Bilingual proficiency in Chinese and English is preferred.
Working Conditions:
Work is performed in both an office and manufacturing environment, requiring adherence to safety protocols.
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