Chemical Scientist - Medical Diagnostic Devices
Scientist Position (qLabs®)
Micropoint Bioscience, Inc., a global provider of Point of Care (POC) testing systems and solutions, is seeking a highly motivated Scientist to join its product development in support of MBI’s qLabs® POC testing product pipelines.
Job Duties include:
- Work with qLabs® lead scientist and product manager to research, develop and improve medical POC diagnostic products
- Participate in POC testing product development including feasibility, verification and validation, manufacturing transfer to ensure that products are in compliance with FDA and EU regulatory requirements and standards for clinical in vitro diagnostics applications.
- Prepare/fabricate disposable qLabs® microfluidic devices for coagulation test such as PT/INR, APTT, fibrinogen and clotting time using laboratory equipments: from reagent formulation, instrument/equipment programming, reagent dispensing, and parts prototyping/assembly up to complete device system.
- Conduct experiments on human/animal specimens (i.e., whole blood and plasma) with standard laboratory instruments to systematically verify and validate performance of the qLabs® devices and systems, ensuring that it meets or exceeds claims of product specifications and regulatory requirements.
- Analyze, summarize, and report data generated from experiments, draw conclusion from experimental results and suggest follow-up actions based on prior experimental findings.
- Assist in transfer of product development to manufacturing, providing detailed and complete technical information and documents related to the transfer process.
- Work closely with QC Department in providing Design Control documents by following historic documents and resolving issues involving parts/products quality and regulatory/audit requirements.
- Provide technical support to qLabs® products marketing and sales
- Perform other duties and assume additional responsibilities as required. Perform other assignments and tasks as directed.
- Coordinate with other researchers and professionals in support of internal and external audits.
Job qualifications include:
- PhD in Analytical Chemistry, Chemical Engineering or related fields with at least 2 years experience
- Lab experience with biosensors, microfluidic devices or nucleic acids analysis preferred
- Experience in LabVIEW or Python programming is a plus
- Strong written and verbal communication skills. (Mandarin language is a plus)
- Ability to learn new skills and work in a fast-paced, highly productive and changing environment; flexibility and quick adaptability to changing priorities.