Director, Organ Health IVD Product Development
Core
Lead the end-to-end development, verification, and validation of next-generation sequencing (NGS) based In Vitro Diagnostic (IVD) devices for organ health, serving as a companion diagnostic (CDx) assay.
Role type
Director, Organ Health IVD Product Development
Builds
FDA Class III (PMA) regulated diagnostic products for germline mutations (SNVs, indels, CNVs)
Domain
Molecular diagnostics / Genetic testing / Organ health
Deliverable
production ML models
Required skills
NGS-based assay design and validation, FDA PMA pathway expertise, germline mutation analysis, team leadership for scientific/technical teams, analytical performance strategy, regulatory compliance (ISO 13485, 21 CFR Part 820)
Preferred skills
PMA/De Novo submission experience, LDT to IVD translation, bioinformatics pipeline integration, orthogonal test validation (Sanger, qPCR, ddPCR)
Technologies
NGS, Sanger sequencing, qPCR, ddPCR, MLPA
Responsibilities
Own technical strategy and phase-gated development process, ensure FDA Class III compliance, lead analytical performance strategy, partner on statistical analysis plans, transfer assays to commercial lab/manufacturing, serve as SME for FDA/pharma interactions, build and retain high-performing teams, manage risk and budget
Seniority
Director, hands-on IC with team leadership
