Process Engineer I

Ready to redefine what's possible in molecular diagnostics?

Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At BillionToOne, we've built something extraordinary—a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today. Our people are our greatest asset: talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion—every innovation you contribute helps remove fear of unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help build the future of precision medicine, this is where you belong.

We are looking for a Process Engineer I to join our growing superstar Process Engineering team in support of clinical patient testing in our high throughput CLIA lab. The Process Engineer is responsible for (1) developing process scale-up strategy and capability, (2) reacting to performance trends/declines/anomalies in production data and developing/validating chemistry and/or process changes to regain stable performance,  (3) developing FDA/GMP/ISO compliant Scale-up, V&V, and tech transfer procedures, and (4) identifying and evaluating new external technologies which may aid in outpacing BTO’s rapid growth in commercial volume. This role will enable an individual to flex their skills in process engineering, med device development, statistical analysis, experimental design, and data science (amongst many more).  This role will help to build upon the strong technology and execution found within BTO’s walls, and will help us pave the way for replicating our prenatal success in the oncology space. This is considered an onsite role and will require the majority of days to be spent in the office.

Responsibilities:

• Plan and execute scale-up efforts for new NIPT assays.
• Build upon the existing statistical Process Control system to enable ever decreasing failure rates and ever increasing assay performance.
• Source and evaluate external technologies which might benefit COGS, process throughput, assay performance, or other key operational metrics.
• Work with RnD 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. 
• 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 short term and long term solutions. 
• Develop effective training plans for clinical personnel on modified/improved workflows.
• Generate proper documentation for all troubleshooting and qualification.

Requirements:

• Minimum Bachelor’s degree or equivalent degree in biology, bioengineering, or related sciences (Master’s preferred)
• At least 3-4 years of experience with molecular biology techniques in a research or clinical laboratory
• Proficiency in R or python
• Strong Statistical Analysis skills 
• Experience designing rigorous, well controlled studies
• 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
• Possess logical troubleshooting skills
• Experience with automation or clinical laboratory experience is a bonus

Nice-To-Haves:

• Start-up experience
• Knowledge of medical genetics
• Experience in a cell-free DNA setting
• Experience with 6-sigma, Lean, JIT, TPS
• Experience with CLIA/CAP, 510K, PMA, and other regulatory requirements

Benefits And Perks:

• Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
• Open, transparent culture that includes weekly Town Hall meetings
• The ability to indirectly or directly change the lives of hundreds of thousands patients
• 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%)
• Free UNITY Complete NIPT testing for employees & spouses
• 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)

At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based on experience and salary/equity options split that the candidate chooses), (2) generous equity options offering, (3) corporate bonus program, on top of (4) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.).

For this position, we offer a total compensation package of $146,611 per year, including a base pay range of $104,040 - $119,646 per year.

BillionToOne is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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BillionToOne is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. Our revolutionary QCT molecular counting technology enhances disease detection resolution by over a thousandfold using cell-free DNA—a breakthrough that's already transformed the lives of over half a million patients worldwide.

Our Impact: We've pioneered game-changing diagnostic solutions that are redefining industry standards. Unity Complete™ stands as the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from a single maternal blood sample. In oncology, our Northstar® liquid biopsy test uniquely combines treatment selection with real-time monitoring, giving oncologists unprecedented precision in cancer care.

Our Growth: From $0 to $125 million in Annual Recurring Revenue in just four years. We've raised close to $400 million in funding, including a $130 million Series D round in June 2024, achieving a valuation of over $1 billion. This backing comes from world-class investors including Hummingbird, Adams Street Partners, Neuberger Berman, Baillie Gifford, and Premji Invest.

Our Recognition: Forbes recently named us one of America's Best Startup Employers for 2025, and we were awarded Great Place to Work certification in 2024—with an incredible 100% of our people reporting they are willing to give extra to get the job done. These honors recognize not just our innovation but the exceptional culture we've cultivated—one that remains authentically collaborative and transparent even as we've scaled.

Our Future: Headquartered in Menlo Park with facilities in Union City, California, we're continuing to push the boundaries of what's possible in molecular diagnostics. Recent clinical outcomes data for Unity Fetal Risk Screen and new advances in cancer diagnostics prove we're just getting started.

At BillionToOne, you'll join a diverse team of passionate innovators who believe that the best science happens when brilliant minds collaborate openly, think boldly, and never lose sight of the patients whose lives depend on our work.

Ready to help us change the world, one diagnosis at a time?

Learn more at www.billiontoone.com