Director, Organ Health IVD Product Development (NGS)

Location: Austin, TX; other location: San Carlos, California, United States

Salary: $185,000–$231,200 USD annually

Company

hirify.global develops cfDNA testing and personalized genetic diagnostics for oncology, women’s health, and organ health.

What you will do

• Own technical strategy and phase-gated development, design verification, and validation for NGS-based IVD companion diagnostic devices characterizing germline SNVs, indels, and CNVs.
• Lead analytical performance strategies covering accuracy, precision, interference, stability, and related evidence for regulatory submissions.
• Partner with Regulatory Affairs, clinical, biostatistics, bioinformatics, software engineering, research, manufacturing, and commercial teams on development, transfer, study design, and go/no-go decisions.
• Serve as technical subject matter expert in FDA and pharma partner interactions, including defense of performance evidence and approval strategy.
• Build and retain a high-performing organization of managers and scientists while managing budgets, vendors, technical risks, and ISO 14971 mitigation and escalation.
• Ensure QMS and design-control requirements are integrated throughout product development and support assay transfer to commercial laboratories and manufacturing.

Requirements

• Advanced degree such as PhD, MD, or equivalent in Molecular Biology, Biomedical Engineering, Life Sciences, or a related field; an MS with additional relevant industry experience may be considered.
• 6+ years of experience in IVD or diagnostic device development under design controls.
• 5+ years of experience directing scientific or technical teams.
• Deep expertise in complex NGS-based diagnostic assays, including assay design, analytical validation, and transfer to a commercial laboratory or manufacturing environment.
• Direct experience with FDA interactions, such as Pre-Submission meetings, for molecular diagnostic or NGS-based devices.
• Experience with germline molecular diagnostics, design-controlled product development, clinical validation, and analytical performance characterization of NGS assays.
• Working knowledge of FDA premarket pathways for high-complexity IVD approvals and deep knowledge of 21 CFR Parts 820/QMSR, 809, and 814, ISO 13485:2016, ISO 14971, and IVDR.
• Ability to build and develop high-performing teams, drive execution in a matrixed organization, translate device-development requirements for technical and non-technical audiences, and provide data-backed updates.

Nice to have

• Principal technical contribution to a PMA, De Novo, or Breakthrough Device submission for an NGS-based germline assay.
• Experience with clinical trial assays and bridging studies to a final IVD candidate.
• Experience translating Laboratory Developed Tests into FDA-regulated IVD products.
• Experience with bioinformatics pipelines and companion software regulated under IEC 62304.
• Experience developing and validating orthogonal tests such as Sanger sequencing, qPCR, ddPCR, or MLPA for NGS accuracy validation.

Culture & Benefits

• Full-time role with benefits including medical, dental, vision, life, disability, 401(k), commuter benefits, and pregnancy and baby-bonding leave.
• Eligible employees and immediate family members receive free testing and fertility-care benefits.
• Work alongside statisticians, geneticists, physicians, laboratory scientists, software engineers, and other cross-functional specialists.
• Equal opportunity workplace with inclusive collaboration across diverse backgrounds and perspectives.