BillionToOne · 2 hours ago
Senior Process Engineer, Oncology
Menlo Park, CA
Full-time
Onsite
Senior Level
$127K/yr - $169K/yr
5+ years expBillionToOne is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. They are seeking a Senior Process Engineer to develop and maintain process monitoring tools, enhance product performance, and mentor junior engineers within their high throughput CLIA/CAP lab.
BiotechnologyGeneticsHealth DiagnosticsMedical
Responsibilities
Develop strategies to support >3X annual growth in commercial volume
Build tools and processes to enhance statistical Process Control to enable increasing assay performance and decreasing failure rates during rapid scale-up
Mentor junior engineers and help to establish strong skills and industry best practices across the growing PE team
Plan studies in conjunction with R&D to identify CPPs, process tolerances, and failure modes during late stage product development
Work with Bioinformatics and data science to translate assay CQAs into impactful and actionable process monitoring tools
Develop new data and information handling tools to aid in efficient sample processing within the clinical laboratory
Source and evaluate external technologies which might benefit COGS, process throughput, assay performance, or other key operational metrics
Apply six sigma, Design-for-quality, and 5S frameworks to existing or new processes to improve both capability, scalability, and quality of molecular diagnostic assays
Support high throughput CLIA lab through troubleshooting instrumentation and re-qualifying instrumentation back into clinical use
Identify root causes for process and instrument errors and develop long term solutions
Qualification
Required
Bachelor's or Master's (preferred) degree 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 and/or python
Proficiency in handling complex data sets, including back-end data wrangling, database querying, and dashboard development
Strong Statistical Analysis skills
Strong Experience designing rigorous, well controlled studies
Experience with data presentation and technical report authoring
Experience working with GMP, ISO, or equivalent highly-regulated 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
Possess logical troubleshooting skills
Experience with automation or clinical laboratory experience is a bonus
Preferred
Start-up experience
Experience in a cell-free DNA setting
Knowledge of molecular oncology
Experience with CLIA/CAP, 510K, PMA, and other regulatory requirements
Experience with 6-sigma, Lean, JIT
Benefits
Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)
Free daily on-site lunches provided from top eateries
A variety of perks on campus (state of the art gym, restaurant)
Free on-site EV charging (compatible with all EVs, including Tesla)
Very generous fully paid parental leave
Company
BillionToOne
BillionToOne is a precision diagnostics company that focuses on genetic testing for disease detection.
501-1000 employees
H1B Sponsorship
BillionToOne has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (6)
2023 (2)
2022 (2)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$425.9MKey Investors
Premji InvestBridge BankHummingbird Ventures
2025-11-06IPO
2024-06-21Series D· $130M
2022-12-15Series C· $48.5M
Leadership Team
J
Jean Hayden
VP of Operations and Chief of Staff to the CEO
Oguzhan Atay
Co-founder and CEO
Recent News
Norwest
2025-12-31
2025-12-10
Company data provided by crunchbase