Director, Organ Health IVD Product Development

Natera • Austin, TX

18h • $185,000 - $231,200

About The Position

Natera is seeking a Director of Product Development to lead development, verification, and validation of Organ Health in vitro diagnostic (IVD) products from feasibility exit through regulatory submission and post-market support. The role owns technical strategy and execution for next-generation sequencing (NGS)-based IVD devices that characterize germline mutations and serve as companion diagnostic assays. It also leads the preparation of performance data packages and approval strategies for regulatory submissions.

The Director builds and develops teams of scientists and managers, oversees program budgets and vendor partnerships, and works across regulatory, clinical, biostatistics, bioinformatics, software engineering, research, commercial, and operations teams. The position serves as a technical subject matter expert in FDA and pharmaceutical partner interactions, supports assay transfer to commercial laboratories and manufacturing, and grounds product development in applicable quality systems, design controls, and regulatory requirements.

Requirements

• 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.
• At least 6 years of experience in IVD or diagnostic device development under design controls.
• At least 5 years of experience directing scientific or technical teams.
• Deep technical expertise in complex NGS-based diagnostic assays, including assay design, analytical validation, and transfer to a commercial laboratory or manufacturing.
• Direct experience with FDA interactions, such as Pre-Submission meetings, for a molecular diagnostic or NGS-based device.
• Experience in molecular diagnostics for germline-based assays, including SNVs, indels, and CNVs.
• Working knowledge of FDA premarket pathways for high-complexity IVD approvals.
• Deep knowledge of FDA regulations (21 CFR Part 820/QMSR, Part 809, and Part 814), ISO 13485:2016, ISO 14971, and IVDR.
• Ability to communicate clear, outcome-driven, data-backed updates to internal and external stakeholders, including the FDA and executive leadership.
• Ability to translate device development requirements for technical and non-technical teams and enable robust development processes and performance study designs.
• Demonstrated experience building and developing high-performing teams, including managers and senior scientists, and driving execution across functions in a matrixed organization.
• Strong understanding of germline-based assay diagnostics, design-controlled product development, clinical validation, and analytical performance characterization of NGS assays.
• Solutions-oriented approach to technical challenges and cross-functional team dynamics.

Nice To Haves

• Served as a principal technical contributor on a PMA, De Novo, or Breakthrough Device submission for an NGS-based germline assay.
• Experience using multiple clinical trial assays for patient enrollment and subsequently bridging to the final IVD candidate through clinical bridging studies.
• Experience translating Laboratory Developed Tests into FDA-regulated IVD products.
• Experience with bioinformatics pipelines and companion software as components of a regulated IVD under IEC 62304.
• Experience developing and validating orthogonal tests, such as Sanger sequencing, qPCR, ddPCR, or MLPA, to validate NGS accuracy in challenging genomic regions.

Responsibilities

• Own technical strategy and phase-gated execution of development, design verification, and validation studies for NGS-based IVD devices used as companion diagnostic assays for germline mutations.
• Ensure compliance with applicable FDA Class III (PMA) design and development requirements.
• Own analytical performance strategy for germline assays, including accuracy, precision, interference, and stability, in partnership with Regulatory Affairs, biostatistics, bioinformatics, and research teams.
• Support robust assay transfer to the commercial laboratory and manufacturing in coordination with design transfer and operations teams.
• Partner with clinical and biostatistics leaders on statistical analysis plans for approvable device performance claims in intended-use populations.
• Coordinate cross-functional development with bioinformatics, biostatistics, software engineering, clinical, regulatory, and commercial teams; align efforts with business goals and drive resourcing and phase-gate go/no-go recommendations.
• Deliver analytical performance data packages for regulatory submissions and develop approval strategies with Regulatory Affairs.
• Serve as the technical subject matter expert in FDA and pharmaceutical partner correspondence and meetings, defending performance evidence with data.
• Use the Quality Management System and regulatory guidance as foundations for product development.
• Build, develop, and retain a high-performing organization of scientists and managers, while optimizing program budgets and external vendor partnerships.
• Identify technical and timeline risks using data, provide ISO 14971 risk management deliverables, and make risk-based mitigation and escalation decisions.

Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401(k) benefits.
• Commuter benefits.
• Employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree