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Salary: USD 128,622 - 150,058 / annual
BillionToOne is a publicly traded molecular diagnostics company transforming healthcare through cell-free DNA technology. The company has grown from $0 to $400M+ annualized revenue in 6 years and recently completed a successful IPO in 2025. With over 700 employees and facilities in Menlo Park, Union City, and an upcoming Austin lab in 2027, BillionToOne is scaling rapidly.
The Senior Process Engineer will join the Process Engineering team supporting clinical patient testing in a high-throughput CLIA laboratory. This is a mentorship-track role for an experienced engineer ready to drive operational excellence and innovation.
Key Responsibilities:
- Source and evaluate external technologies to improve COGS, throughput, assay performance, and turnaround time
- Develop strategies to support 2-3X annual growth in commercial volume
- Build upon the existing statistical Process Control system to reduce failure rates and improve assay performance
- Mentor junior engineers and establish best practices across the growing PE team
- Facilitate technology transfer between R&D and clinical laboratory, identifying critical process parameters, tolerances, and failure modes
- Collaborate with Bioinformatics and Data Science to translate assay CQAs into actionable process monitoring tools
- Develop data and information handling tools for efficient sample processing and process monitoring
- Apply Six Sigma, Design-for-Quality, and 5S frameworks to improve capability, scalability, and quality of molecular diagnostic assays
- Lead root cause analyses to identify and solve process issues with a focus on long-term solutions
Requirements:
- Bachelor's, Master's, or Ph.D. in biology, bioengineering, or related sciences
- At least 5-6 years of experience with molecular biology techniques in a research or clinical laboratory
- Proficiency in R, Python, or an adjacent coding language
- Strong statistical analysis skills
- Strong experience designing rigorous, well-controlled studies in a molecular biology environment
- Experience with data presentation and technical report authoring
- Experience working with GMP, ISO, or equivalent environments, with strong knowledge of Quality Management Systems and practices
- Excellent attention to detail
- Effective written and verbal communication skills
- Experience mentoring junior team members
- Logical troubleshooting skills
Nice-to-Haves:
- Start-up experience
- Knowledge of medical genetics
- Experience in a cell-free DNA setting
- Experience with Six Sigma, Lean, JIT, or TPS
- Experience with CLIA/CAP, 510K, PMA, and other regulatory requirements
- Experience with automation or clinical laboratory experience
