Process Engineering Associate I/II, Oncology

About the role

We are seeking a Process Engineering Associate to join our dynamic Process Engineering team, focusing on clinical patient testing within our high-throughput CLIA laboratory. This role involves developing and implementing tools to optimize clinical workflows, analyzing process data from our assays, and identifying recurring errors to develop effective solutions. Candidates will have the opportunity to apply programming skills in Python and R to solve real-world challenges in a fast-paced, clinical environment. The position is primarily onsite, located in Menlo Park, CA, and offers a chance to contribute directly to improving diagnostic processes that impact patient care.

Key facts

What you'll do

• Use engineering principles to improve and streamline molecular biology methods used in clinical testing, ensuring high accuracy and efficiency.
• Conduct experiments to diagnose, verify, and confirm the root causes of errors in high-throughput molecular biology workflows, including sample processing and instrument performance.
• Collect, organize, and analyze large datasets related to process performance, stability, and error rates, using statistical and analytical tools to identify trends and areas for improvement.
• Develop and implement software tools and scripts, primarily using programming languages such as R and Python, to facilitate efficient sample processing, data analysis, and process monitoring within the clinical lab.
• Use data analysis to quantitatively assess process efficiency, identify sources of errors, and evaluate the impact of process changes.
• Detect, troubleshoot, and resolve process and instrument errors, developing both immediate corrective actions and long-term process improvements to prevent recurrence.
• Collaborate with cross-functional teams, including R&D, Quality, and Operations, to support the transfer of new technologies and processes from research to clinical implementation.
• Design, document, and deliver training programs for clinical staff on updated workflows, new equipment, and process changes to ensure compliance and consistency.
• Maintain thorough documentation of troubleshooting activities, process validations, and process improvements, ensuring compliance with CLIA and other regulatory standards.
• Participate in process qualification activities, including validation, verification, and ongoing monitoring of process performance.
• Assist in developing and refining standard operating procedures (SOPs) to reflect process improvements and regulatory requirements.
• Contribute to continuous improvement initiatives by analyzing process data, proposing modifications, and implementing solutions to enhance throughput and quality.

Requirements

• Bachelor's degree or equivalent in biology, molecular biology, biomedical engineering, or related clinical sciences.
• Minimum of 6 months of experience working with molecular biology techniques in either a research or clinical laboratory setting.
• Strong attention to detail and a meticulous approach to troubleshooting and data analysis.
• Excellent written and verbal communication skills, capable of documenting findings clearly and collaborating effectively with team members.
• Proven ability to troubleshoot complex processes and systems logically and systematically.
• Experience with automation, laboratory instrumentation, or clinical laboratory workflows is preferred but not required.
• Familiarity with data analysis, statistical methods, and programming in R and Python is highly desirable.
• Ability to work independently and as part of a multidisciplinary team in a fast-paced environment.
• Knowledge of CLIA regulations and quality systems is a plus.
• Demonstrated problem-solving skills and a proactive attitude toward process improvement.

Nice to have

• Experience working in a startup environment or a rapidly evolving biotech setting.
• Knowledge of next-generation sequencing (NGS) technologies and workflows.
• Background in molecular oncology or cell-free DNA analysis.
• Prior experience with assay transfer, validation, and regulatory compliance in a clinical laboratory.
• Familiarity with laboratory automation tools and data management systems.

Skills & tools

• Proficiency in R and Python for data analysis, scripting, and software development.
• Strong understanding of molecular biology techniques, including PCR, NGS, and sample preparation workflows.
• Ability to analyze large datasets and interpret process performance metrics.
• Experience with laboratory instrumentation and automation systems is a plus.

Practical notes

BillionToOne offers a competitive total compensation package of $104,322 annually, which includes a base salary range of $75,029 to $85,748, depending on experience and the specific salary/equity options selected. Benefits include comprehensive medical coverage, a 401(k) plan with company matching, and generous parental leave policies. The role is based onsite in Menlo Park, CA, and does not include remote, hybrid, or work-from-home options. This position is ideal for candidates who thrive in a fast-paced, innovative environment and are committed to improving healthcare through advanced diagnostics.

BillionToOne is an equal opportunity employer and values diversity in the workplace. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment where all employees can thrive.

For more information about our privacy practices, please review our Privacy Policy available on our website.

BillionToOne is dedicated to making advanced diagnostic tests accessible to everyone. Our innovative QCT molecular counting technology significantly enhances disease detection capabilities. Our flagship products, such as Unity Complete™ and Northstar®, are transforming patient care in prenatal and oncology diagnostics.

Headquartered in Menlo Park, CA, BillionToOne also has facilities in Union City, CA, and plans to open a new lab in Austin, TX, in 2027. Join us as we continue to innovate in the field of molecular diagnostics and make a meaningful impact on healthcare worldwide.

If you are passionate about advancing healthcare through technology and process improvement, we encourage you to apply. Learn more about us at billiontoone.com.