Job Description:

• 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.

Requirements/Qualifications:

• 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.