Think team by partnering directly across research, bioinformatics, biostatistics, software, clinical, regulatory, and commercial functions to deliver design-controlled IVD products in a highly cross-functional environment Communicate portfolio status, risks, and tradeoffs to executive leadership and drive alignment on enterprise priorities Ensure the organization operates within Natera’s QMS and all applicable guidance (ISO 13485:2016, FDA QMSR (21 CFR Part 820), ISO 14971, IEC 62304, etc), and partner with Quality to maintain audit readiness and strengthen design control practices. You will take ownership of product development strategy and execution, guiding Next-Generation Sequencing (NGS) and cell-free DNA-based (cfDNA) In Vitro Diagnostic (IVD) products from feasibility through FDA Premarket Approval (PMA) and post-market support.