R53345E41

台北市

中高階

醫療器材設備

產品設計

1. Review and supervise R&D activities of design control (new products) and design change (existing products) meanwhile ensure the competition and compliance of product technical files.
2. Evaluate and assess the feasibility of new product development or product specification change including user needs, technic analysis, IP impact, and undertaken cost-benefit analysis.
3. Plan and supervise the installation, testing, establishment, repairing and maintenance of equipment (in- house and outsourcing).
4. Take a role as a coordinator within the R&D team across all departments of Galemed group and external development partners, equipment and component suppliers, outsourcing suppliers, and technology partners.
5. Take a role as a coordinator within the R&D team for internal or external design transfer to manufacturing line and co-work with internal or external partners to ensure the processes of production properly.
6. Play an active role in Galemed group to analysis any non-conformity and resolve certain issue cross-functionally.

NTD / 面議 （經常性薪資達4萬元或以上）

依法令規定之相關福利 / 勞、健保 / 勞工退休金提撥

1. FDA Quality System Regulations, ISO 13485;2016 and risk management requirements.
2. EU Medical Device Regulation and requirements of USFDA 510k application (plus)
3. Plastic injection molding, mechanism
4. 5+ years of work experience in medical devices or bio-science industry
5. 8+ years in R&D and 5+ years management of people
6. ODM or OEM or co-manufacturing experience in medical devices or bio-science industry
7. Bachelor of Engineering or science with a postgraduate qualification in biomedical/mechanical engineering
8. Bilingual in Mandarin and English

英語(很流利)

大學以上

不需負擔管理責任

需出差

周休二日

1人

2024 / 03 / 19