Novel Microdevices is currently looking for a highly motivated Product Research Scientist to join our R&D team as a key member in developing IVD point-of-care molecular diagnostic assays for rapid detection of infectious pathogens. The position is a technical role on the assay development team under the guidance of the Senior Scientific Research Manager and will provide an opportunity to participate in many aspects of in vitro diagnostics design, development, manufacturing, and commercialization processes. The main responsibilities include:
- Design, optimize, and characterize the sample preparation and amplification of nucleic acids assay components of IVD microfluidic-based test cartridge for transfer to manufacturing.
- Experimental study planning, hands-on execution, analysis, reporting, and documenting per GLP and QMS of multiplex nucleic acid amplification assays.
- Develop, integrate and qualify multiplex molecular diagnostic assays on automated systems.
- May participate in design risk evaluation, mitigation and management
- Adhere to FDA design control requirements for IVD product development
- Execute analytical studies to verify product design and validate performance of the assays and providing relevant data and information in support of regulatory submissions.
- Actively participate in defining project activities to achieve goals in a timely manner.
- Regularly present data and findings to technical teams for discussion.
- Work effectively with technical team members and cross functional teams.
- Knowledge in chemistry, microbiology, biochemistry, infectious pathogens, microfluidics, and molecular biology.
- Experienced in sample preparation and nucleic acid extraction methods
- Experienced in developing optimized nucleic acid amplification / detection technologies (LAMP, PCR or RT-PCR)
- Experienced with handling clinical biological samples such as urine, swabs, saliva, and blood
- Experienced working BSL-2 laboratories
- Experienced with designing experiments, documenting the work, evaluating and interpreting results, and reporting.
- Self-starter with ability to work independently and effectively as part of a team with minimal supervision
- Ability to solve problems quickly by thinking outside the box and using effective troubleshooting skills
- Excellent team communication skills.
- Strong organizational, interpersonal skills, and can-do attitude
- Ability to work in a results-driven R&D environment
- Experienced in primer design and bioinformatics tools
- Experienced with point-of-care molecular diagnostics
- Experienced with design of experiments (DOE) methods
- Experienced in IVD product development for FDA submissions
- Experienced in FDA IVD study design, design control and design transfer to manufacturing
- Advanced degree in relevant life science/engineering
- Worked in a regulated industry position
- Full time