Senior Commercialization Process Engineer (Molecular Diagnostics)

Location: San Carlos, California, United States

Salary: $141,636–$177,045 USD annually, plus potential performance bonus and long-term equity awards.

Company

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

What you will do

• Embed in New Product Introduction programs from feasibility through design transfer, providing bench-level laboratory operations input on workflow design, automation feasibility, and scalability.
• Evaluate WES, WGS, RNA-seq, histology, H&E, and IHC workflows with assay development, pathology, automation, software engineering, and operations teams.
• Act as the Lab Operations liaison to informatics and LIMS teams, ensuring sample tracking, software systems, and data pipelines are production-ready and validated.
• Assess workflows through hands-on testing and modeling to identify bottlenecks, manual steps, failure modes, and production risks.
• Contribute to User Needs documentation, FMEA, process risk assessments, instrument qualification, automation integration, and the NPI Launch Playbook.
• Support end-to-end testing in production environments and document operational requirements and improvement recommendations.

Requirements

• Bachelor’s or master’s degree in Bioengineering, Molecular Biology, Biochemistry, Biomedical Engineering, or a closely related discipline; equivalent education and experience may be considered.
• Bachelor’s degree plus 10 years of relevant experience, or master’s degree plus 7 years, or PhD plus 4 years.
• Strong scientific background in molecular and cell biology, biotechnology, or biochemistry.
• Working knowledge of CAP, CLIA, NYSDOH, and applicable GxP requirements, with the ability to follow and establish SOPs.
• Bench-level familiarity with WES, WGS, RNA-seq, and other scientific workflows, including execution, troubleshooting, evaluation, and scalability implementation.
• Experience with NPI, product development, or assay launch processes and with the intersection of laboratory operations and informatics or LIMS.
• Strong knowledge of laboratory systems, automation, software integration, and process optimization projects.
• Proficiency with Excel and data analysis, including basic statistical analysis.
• Strong written and verbal communication skills, including technical reports, SOPs, and training documentation, plus the ability to work cross-functionally and manage multiple priorities.

Nice to have

• Experience with Python, SQL, or AI-enabled data analysis tools.

Culture & Benefits

• Full-time employment in a fast-paced, cross-functional environment spanning scientific, engineering, and operational teams.
• Comprehensive medical, dental, vision, life, and disability benefits for eligible employees and dependents.
• 401(k) with company match, paid time off, company holidays, commuter benefits, wellness benefits, and work-life programs.
• Free testing for employees and immediate family members, plus fertility care benefits and pregnancy and baby bonding leave.
• Annual performance incentive bonus, long-term equity awards, and employee referral program.