Director, ECD Development (IVD)

Location: Remote USA; San Carlos, California listed as the role location.

Salary: $228,600–$285,800 USD annually.

Company

hirify.global develops cell-free DNA testing and personalized genetic diagnostics for oncology, women’s health, and organ health.

What you will do

• Lead development, design verification, and validation of early cancer detection IVD products using cfDNA, methylation, and other analytes.
• Own analytical performance strategies covering sensitivity, precision, linearity, interference, stability, and related studies.
• Deliver performance data packages and approval strategies supporting FDA Class III PMA submissions.
• Serve as the technical subject matter expert in FDA correspondence, Pre-Submission meetings, and regulatory discussions.
• Partner with clinical, regulatory, biostatistics, bioinformatics, software engineering, commercial laboratory, and manufacturing teams.
• Build and retain a high-performing organization while managing budgets, vendors, timelines, and technical risks.

Requirements

• Advanced degree 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 developing IVD or diagnostic devices under design controls.
• 5+ years of experience directing scientific or technical teams.
• Deep expertise in complex NGS-based diagnostic assays, analytical validation, and transfer to commercial laboratories or manufacturing.
• Direct FDA interaction experience for molecular diagnostic or NGS-based devices, including knowledge of PMA and other high-complexity IVD pathways.
• Knowledge of FDA regulations, ISO 13485:2016, ISO 14971, IVDR, and IEC 62304.

Nice to have

• Technical contribution to a PMA, De Novo, Breakthrough Device, IVDR Class C/D, PMDA, or NMPA submission.
• Experience with pivotal clinical validation studies for cancer screening or early detection.
• Experience translating Laboratory Developed Tests into FDA-regulated IVD products.
• Experience with bioinformatics pipelines and companion software for regulated IVD products.

Culture & Benefits

• Cross-functional environment spanning scientific, clinical, regulatory, software, laboratory, and business disciplines.
• Medical, dental, vision, life, and disability benefits for eligible employees and dependents.
• Free testing for employees and immediate family members, plus fertility care benefits.
• Pregnancy and baby bonding leave, 401(k), commuter benefits, and employee referral benefits.