- Opportunity for Sr. R&D engineers to be a manager
- New product development opportunity for well-known medical device brand
About Our Client
This position is a confidential search, more details would be discussed when process to interviews.
- Manage R&D activities of new products design and existing products design change meanwhile ensure the competition and compliance of product technical files.
- Evaluate and assess the feasibility of new product development or product specification change including user needs, technical analysis, IP impact, and undertaken cost-benefit analysis.
- Plan and supervise the installation, testing, establishment, repairing and maintenance of equipment (in- house and outsourcing).
- Coordinator within the R&D team for internal and external design transfer to manufacturing line and co-work with internal or external partners to ensure the processes of production properly.
The Successful Applicant
- Bachelor of Engineering or science with a postgraduate qualification in biomedical/mechanical engineering
- 8+ years of work experience in medical devices or bio-science industry
- 8+ years in R&D and 5+ years project management experience
- ODM or OEM or co-manufacturing experience in medical devices or bioscience industry
- Knowledge of FDA Quality System Regulations, ISO 13485;2016 and risk management requirements.
- EU Medical Device Regulation and requirements of USFDA 510k application (plus)
- Plastic injection molding, mechanism
- Bilingual in Mandarin and English
What's on Offer
* Opportunity for Sr. R&D engineers to be a manager
* New product development opportunity for well-known medical device brand