We are looking for a Development, Process and Engineering Technician to support the RD&production department manager in planning and executing medical device customers' semi-finished product CDMO projects. The successful candidate will carry out development and production activities for semi-finished products of medical implants, and assure execution in the ESH and quality system compliant and know-how protected way.
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 ad skills in operating and trouble shooting for the process, e.g. single screw extrusion, twin screw extrusion, injection molding etc.
- Good experience ad 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.
- Good knowledge about cleanroom and lab utilities engineering and management
- Good knowledge about ISO 13485 and medical device laws and regulations
