We are currently seeking extraordinary, highly motivated individuals to join our research and development team, with a focus on tissue and cell-free DNA liquid biopsy approaches. The successful candidate will develop and optimize cutting-edge diagnostic technologies for use as an IVD. Background in product development for Class II and III assays is preferred. Expertise in design control desired.
Master’s or Ph.D. Degree in Biology or Related Field with a minimum of 1-3 years’ experience in molecular diagnostics or medical device industry
Experience in 510k, PMA submissions, and FDA interactions preferred
Design control, verification and validation protocol expertise required
Expert knowledge of scientific principles and concepts
Oncology and/or diagnostics experience strongly preferred
Experience with next-generation sequencing technology and bioinformatics analyses of cancer strongly preferred
Cross-functional experience working with product development teams