Responsibilities

  • Communicate regularly with researchers, clinicians and industry to conceptualize and design novel, clinically relevant and commercially viable IVD or diagnostic products.
  • Work with Project manager to oversee product development, verification and validation of molecular and immuno diagnostic assays, or novel analytical platforms & diagnostic devices. 
  • Assist in planning and executing experimental procedures in a certified Laboratory to integrate, test and validate novel IVD products and diagnostic systems.
  • Assist design optimisation and verification plans and reports in accordance to ISO 13485. 
  • Assist in landscape study and analysis for market, IP, regulatory requirements. 
  • Assist with clinical trial management. 
  • Work in close partnership with the Project manager to define project plans and budgets, develop timelines, establish and monitor project risks and risk register and coordinate the project teams to achieve project deliverables and objectives in accordance to ISO 13485. 
  • Assist in compiling and communicating project progress reports for milestone reviews with management. 
  • Communicate regularly with other researchers, clinicians and industry to conceptualize and design novel, clinically relevant and commercially viable IVD or diagnostic products. 
  • Assist in biomedical experiments, or software engineering, in product development, verification and validation of molecular and immuno diagnostic assays, or novel analytical platforms & diagnostic devices. 
  • Assist in planning and executing experimental procedures in a certified Laboratory to integrate, test and validate novel IVD products and diagnostic systems.
  • Assist in equipment management, quality assurance, regulatory affairs. 
  • Work closely with the Project manager & Technical lead to perform experiments, documentation, and other R&D related tasks. 
  • Assist in compiling and communicating project progress reports for milestone reviews with management.

Requirements

  • Candidates should be pursuing Bio-Science or engineering or business degree.
  • Interested in process control, regulatory, product development, project coordination. 
  • Open-minded and willing to communicate to various partners.
  • Able to commit for 6 months.
Save