- Support product development work and manage graphic and packaging work.
- Manage the ISO13485 documentation work for instrument and cartridge design
- Support the product verification and validation activities in CM–Include material preparation, test Matrix and test plan.Material management for engineering build and Preproduction activities.
- Support the production activities such as part approval ( repeat tool ), Root cause analysis and manage field return root cause analysis, production issue.
- Manage the prototype and mock up activities.
- Manage the FA activities from CM.
- Support the Tool trial and engineering build buy off activities in Contract Manufacturing.
- 3 years product development and manufacturing experience for Medical device / consumer product.
- Min 3 years of knowledge in plastic injection moulding and metal stamping.
- Preferably possess ISO13485 and ISO14971 knowledge
- Min 2 years of experiences in supporting product verification and validation
- Min 2 years of experiences in managing the product BOM
- Min 2 years of experiences in managing the graphic and packaging of the product.
- Degree in Mechanical engineering or Mechatronics.