Senior Software V&V Engineer

LOCATION: Remote or On-Site Boulder, CO

ABOUT FORESIGHT DIAGNOSTICS (A wholly-owned subsidiary of the company)

Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer.

We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by the company, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us.

Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day.

ABOUT THE ROLE

Our software portfolio spans bioinformatics pipelines, reagent QC systems, liquid handling automation, LIMS/LIS integrations, and NGS analysis tools. Each component carries regulatory obligations under IEC 62304 and ISO 13485, and each needs to be verified and validated with the rigor that clinical diagnostics demands.

This is a senior individual contributor role with real ownership — you'll set the V&V strategy across device software, manage the cadence and prioritization of testing activities, and serve as the quality and engineering bridge between bioinformatics, software, and lab teams. The candidate must bring genuine bioinformatics or computational biology experience: this isn't a role where you can learn the domain on the job.

PRIMARY RESPONSIBILITIES

You'll own verification and validation activities across Foresight's software portfolio — working closely with bioinformaticians, software engineers, and clinical laboratory teams to ensure every system is tested thoroughly and documented completely. In practice, that means:

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• Aligning all software testing processes with IEC 62304 and ISO 13485 design control requirements, and ensuring the team operates consistently within that framework.

• Overseeing V&V activities for pipeline software, lab automation methods, reagent QC software, LIMS/LIS tools, and select laboratory instruments.

• Designing and executing software verification tests for NGS bioinformatics pipelines — including tests for end-to-end analysis workflows and individual NGS algorithms.

• Developing and maintaining test templates, test protocols, and IEC 62304-aligned test cases that are clear, complete, and audit-ready.

• Reviewing executed test cases, assessing variances, and collaborating with the Quality Assurance team to resolve and document findings appropriately.

• Approving test reports and ensuring full documentation compliance under design controls.

• Establishing and maintaining V&V traceability across device software, lab automation tools, and lab instruments — including oversight of software traceability matrices across all device software components.

• Managing the cadence, prioritization, and execution of V&V activities across concurrent programs.

• Traveling to the Foresight lab in Boulder, CO on a regular basis to support testing activities, lab integration work, and cross-functional collaboration.

QUALIFICATIONS

• Required

• 4+ years conducting and overseeing software verification and validation activities for regulated medical device software (510(k) and/or PMA pathways).

• 3+ years designing and executing verification tests specifically for NGS bioinformatics pipelines — including NGS analysis workflows and individual algorithm testing.

• 2+ years of testing experience in cloud environments (AWS or GCP).

• Direct working knowledge of ISO 13485 and IEC 62304 design controls — applied experience, not just familiarity.

• Prior experience working cross-functionally with bioinformaticians, software engineers, and clinical laboratory teams.

• Prior work experience in bioinformatics, computational biology, or a biology-related field — this is a hard requirement for this role.

• Excellent written and verbal communication skills, with the ability to translate complex technical findings into clear, compliant documentation.

• Preferred

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• Testing experience with pipeline orchestration tools such as Nextflow.

• Hands-on exposure to clinical laboratory workflows — CAP/CLIA environment experience is a meaningful advantage.

• Familiarity with LIMS/LIS platforms in a regulated diagnostic context.

• Experience contributing to or preparing for FDA submissions (510(k) or PMA) from a V&V documentation standpoint.

WHY JOIN US

This is a technically sophisticated role at the intersection of bioinformatics and regulated software quality — a combination that's genuinely rare and increasingly in demand as molecular diagnostics scales. You'll work on software systems that directly enable MRD detection for cancer patients, alongside scientists and engineers who take both the science and the standards seriously.

With the company's backing and Foresight's mission, you'll have the resources of an established organization and the ownership opportunities of a focused, growing team. We invest in our people and promote from within for those who deliver.

LOCATION AND TRAVEL

This role offers location flexibility with regular required travel to our Boulder, Colorado laboratory. Travel frequency will be discussed during the interview process and will vary based on program needs, audit schedules, and lab integration milestones. Candidates should be comfortable with periodic in-person presence as a genuine part of the role.

COMPENSATION & TOTAL REWARDS

This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.

This position is also eligible for additional compensation and benefits through the company’s robust Total Rewards program, including:

• Annual performance incentive bonus

• Long-term equity awards

• Comprehensive health benefits (medical, dental, vision)

• 401(k) with company match

• Generous paid time off and company holidays

• Additional wellness and work-life benefits

COMPENSATION RANGE

$108,700.00 - $140,000

OUR OPPORTUNITY

The company™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The company team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join the company, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, the company employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit [link for members] .

The company is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: [link for members]

Please be advised that the company will reach out to candidates with a @ the company  email domain ONLY. Email communications from all other domain names are not from the company or its employees and are fraudulent. The company does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. The company takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information

• BBB announcement on job scams
• FBI Cyber Crime resource page