PREFERRED QUALIFICATIONS: Served as a principal technical contributor on a PMA, De Novo, or Breakthrough Device submission for an NGS-based oncology device, or an equivalent high-complexity IVD approval outside the US (e.g., IVDR Class C/D, PMDA, NMPA). Take ownership of the analytical performance strategy (limit of blank/detection, precision, linearity, interference, stability) for ECD assays, partnering directly with Regulatory Affairs (RA), biostatistics, bioinformatics and research teams.