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Director, ECD Development

Natera· Bio Development
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Hybrid (Remote USA)$228.6k - $285.8kFull-timePosted 5d ago

About the role

Director of Development for ECD IVD products at Natera, leading the development, verification, and validation of cfDNA/methylation-based NGS tests from feasibility through regulatory submission and post-market support. Acts as the technical SME in FDA interactions and builds a high-performing team to deliver PMA/other regulatory submissions.

Responsibilities

  • Own the execution of the technical strategy and phase-gated process of development, design verification, and validation studies for ECD IVD devices utilizing cfDNA, methylation and other potential analytes
  • Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements
  • 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
  • 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 go/no-go recommendations at phase gates
  • Deliver the analytical performance data package supporting Class III PMA submissions, developing a comprehensive approval strategy with RA
  • Serve as the technical subject matter expert in correspondence and meetings with the FDA, defending performance evidence using data
  • Treat Quality Management System (QMS) requirements (ISO 13485:2016, FDA QMSR 21 CFR Part 820, ISO 14971, IEC 62304) and regulatory guidance as the foundation of product development rather than a final check
  • Build, develop, and retain a high-performing organization of scientists and managers, optimizing program budgets and external vendor partnerships
  • Use data to identify technical and timeline risks, including ISO 14971 risk management deliverables, making risk-based decisions on mitigation and escalation

Qualifications

  • Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life Sciences, or a related field; an MS with additional relevant industry experience will be considered
  • 6+ years of experience in IVD or diagnostic device development under design controls
  • 5+ years of experience directing scientific or technical teams

Skills

Required:NGS-based diagnostic assaysFDA interactionsLiquid biopsy / cfDNA diagnosticsRegulatory pathways (PMA/De Novo/IVDR)Cross-functional leadershipRisk management (ISO 14971)
Last updated Oct 22, 2026. Interested? Apply on the company site.

About Natera

A global leader in cfDNA testing

Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.

oncologywomen's healthorgan healthcell-free DNA
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