Research Associate - Medical Diagnostic Devices
Micropoint Bioscience, Inc., a global provider of Point of Care (POC) testing systems and solutions, is seeking a highly motivated Research Associate to join its product development team in support of MBI’s qLabs® POC testing product pipelines.
Job Duties include:
- Work with senior scientist 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.
- Support senior scientist to prepare/fabricate disposable qLabs® coagulation and nucleic acids testing devices: from reagent formulation and dispensing, parts 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.
- Perform and take a leadership role in daily or weekly laboratory tasks such as taking weekly meeting minutes, chemical inventory, reagent preparation, instrument/equipment maintenance, documentation, laboratory clean-up and organization.
- 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:
- B.S. in Analytical Chemistry, Chemical Engineering, Biomedical Engineering or related fields
- Strong written and verbal communication skills with experience in Excel, PowerPoint, and Word programs.
- One or two years of related experience is a plus.
- Chinese 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.