Contract Design Control Scientist (Genomics)

Location: Hybrid role based in South San Francisco, California, United States

Company

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

What you will do

• Author and maintain design-controlled documentation across the product development lifecycle.
• Translate laboratory processes, study plans, analytical data, and software workflows into traceable development reports, specifications, and verification or validation protocols.
• Establish traceability between requirements, design outputs, and verification evidence.
• Review development reports, software scripts, and team resources to synthesize information for controlled documents.
• Create onboarding, training, and departmental practice documentation for R&D and CLIA teams.
• Manage filing, version control, change control, templates, and documentation improvements within quality management systems.

Requirements

• BS or higher in molecular biology, biochemistry, genomics, or a related scientific discipline, or equivalent industry experience.
• 5+ years of experience producing controlled documentation in the medical device, IVD, or life science industry.
• Experience working in regulated environments governed by FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and/or GDPR.
• Experience interpreting software implementations and structured data formats such as JSON and XML.
• Ability to work cross-functionally with Engineering, Product Management, Data Science, Biostatistics, Science, and RA/QA teams.
• Strong scientific literacy, written communication, attention to detail, and knowledge of product-development and change-control processes.

Nice to have

• Experience with MasterControl, Confluence, or similar quality and collaboration platforms.
• Knowledge of LIMS, LIS, LES, ELN, genomics data-analysis pipelines, laboratory instrumentation, and software-compliance requirements.

Culture & Benefits

• 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) benefits, and commuter benefits.
• Work alongside statisticians, geneticists, physicians, laboratory scientists, software engineers, and other multidisciplinary professionals.