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Job Responsibility:
Support RD&production department manager to plan and execute medical device customers' semi-finished product CDMO projects (note: 90% of target end medical implants belong to Class III)
Carry out development and production activities for semi-finished products of medical implants, and assure execution in the ESH and quality system complianced and know-how protected way
Draft SOPs for production and process management when required by RD&production department manager
Support RD&production department manager to manage cleanroom in good way, including cleanliness maintaining, related equipment and utillities routinely monitoring, maintenance reporting, monitoring and feedback.
Requirements:
University (First degree)
Experience of R&D and production in medical device company (who produce Class III medical implants device) is preferred
Good experience and skills in processing medical polymers based mainly on bio-resorbable polymers
Good experience and skills in operating and trouble shooting for the process, e.g. single screw extrusion, twin screw extrusion, injection molding etc.
Good experience and skills in producing monofilament, tube, membrane, composite, molding part is preferred
Experienced practitioner able to work unsupervised in project management and execution including evaluating project feasibility and providing technical suggestion, make execution plan, carry out development and production activities including trouble-shooting etc.
Good skills and experience of coordinating, communicating with others in the teamwork
Good skills and experience of coordinating, communicating with external customer and suppliers
Works without supervision and provides work related data, report and records to business objectives under complianced, quality system required, know-how protection regulated way
Good knowledge about cleanroom and lab utilities engineering and management
Good knowledge about ISO 13485 and medical device laws and regulations
Works without supervision when required on achieving full compliance with applicable rules and regulations in management and/or operations.