R&D Manager ( Medical Device / Plastic injection)

International Permanent
  • 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.

Job Description

- 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

Contact
Laura Wang
Quote job ref
4165740
Phone number
+886 2 8729 8217

Job summary

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Location
Contract Type
Consultant name
Laura Wang
Consultant phone
+886 2 8729 8217
Job Reference
4165740