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Director, Organ Health IVD Product Development
Natera Austin, TX Posted yesterday
About the role
Join Natera as the Director of Product Development for our Organ Health In Vitro Diagnostic (IVD) products.
What you'll do
- Own the execution of the technical strategy and phase-gated process of development, design verification, and validation studies for next-generation sequencing (NGS) based IVD devices to characterize germline mutations…
- Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements
- Take ownership of the analytical performance strategy (accuracy, precision, interference, stability, etc) for germline assays, partnering directly with Regulatory Affairs (RA), biostatistics, bioinformatics and…
- Contribute to the robust transfer of assays to the commercial laboratory and manufacturing in support of the design transfer and operations teams
- Partner with clinical and biostatistics leaders on statistical analysis plans required for approvable device performance claims in clinical intended-use populations
- Think team by partnering directly across bioinformatics, biostatistics, software engineering, clinical, regulatory, and commercial functions to align development efforts with business goals, and drive resourcing and…
What you'll need
Natera lists the full requirements on its posting.