Software Design Quality Engineer

ABOUT FORESIGHT DIAGNOSTICS

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, next-generation sequencing (NGS), and bioinformatics and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, 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.

WHY THIS ROLE EXISTS

As Foresight Diagnostics scales its MRD platform towards broader clinical deployment, the software systems that underpin our products are growing in complexity and regulatory surface area. This role is part of our team that owns the design quality for those systems - ensuring that everything from our bioinformatics pipelines to our software meets standards such as IEC 62304, ISO 13485, ISO 27001, and clinical standards like CAP, CLIA, and ISO 15189. Your work protects the integrity of results that oncologists and their patients depend on.

WHAT YOU’LL DO

Working cross-functionally with clinical lab, R&D, bioinformatics, product development, and regulatory teams, you’ll be the quality partner for software across Foresight’s portfolio. In practice, that means:

• Leading design quality engineering activities across the software development lifecycle - from risk assessments and quality planning through design reviews, V&V, and post-market monitoring.
• Reviewing and approving design input/output artifacts including requirements documents, design specifications, code reviews, and verification and validation test plans and reports.
• Ensuring all software design controls are compliant with IEC 62304, ISO 13485, and other applicable regulatory guidance - and that compliance is demonstrated, not assumed.
• Developing and maintaining risk analysis tools and risk management plans across Foresight’s suite of software systems.
• Creating and revising SOPs to define software quality and release readiness requirements, shepherding documents through design and documentation control processes.
• Supporting and leading cross-functional validation planning efforts for software systems, coordinating with teams on timely remediation of compliance gaps.
• Managing NCR and CAPA processes - investigating and resolving end-user issues, tracking metrics and closing the loop.
• Supporting cybersecurity process adherence across the product portfolio.
• Participating in external audits with regulatory bodies including CAP, CLIA, and ISO certification bodies.
• Monitoring process efficiency through internal audits and reporting that drives real improvement.

Leading design quality engineering activities across the software development lifecycle - from risk assessments and quality planning through design reviews, V&V, and post-market monitoring.

Reviewing and approving design input/output artifacts including requirements documents, design specifications, code reviews, and verification and validation test plans and reports.

Ensuring all software design controls are compliant with IEC 62304, ISO 13485, and other applicable regulatory guidance - and that compliance is demonstrated, not assumed.

Developing and maintaining risk analysis tools and risk management plans across Foresight’s suite of software systems.

Creating and revising SOPs to define software quality and release readiness requirements, shepherding documents through design and documentation control processes.

Supporting and leading cross-functional validation planning efforts for software systems, coordinating with teams on timely remediation of compliance gaps.

Managing NCR and CAPA processes - investigating and resolving end-user issues, tracking metrics and closing the loop.

Supporting cybersecurity process adherence across the product portfolio.

Participating in external audits with regulatory bodies including CAP, CLIA, and ISO certification bodies.

Monitoring process efficiency through internal audits and reporting that drives real improvement.

WHAT YOU’LL BRING

Required

• Minimum of 3-5 years of software quality engineering experience in a regulated environment (FDA, ISO, CAP/CLIA, or equivalent).
• Hands-on experience executing IEC 62304 software development lifecycle requirements in conjunction with ISO 13485 design controls.
• Demonstrated ability to define, implement, and maintain compliant software development, execution, and documentation.
• Strong autonomy and project ownership: you can drive complex, cross-functional work without waiting to be told what to do next.
• Bachelor’s degree in software engineering, computer science, information technology, or a closely related field.
• Exceptional interpersonal and collaboration skills - you work as well with lab scientists as you do with software engineers.

Minimum of 3-5 years of software quality engineering experience in a regulated environment (FDA, ISO, CAP/CLIA, or equivalent).

Hands-on experience executing IEC 62304 software development lifecycle requirements in conjunction with ISO 13485 design controls.

Demonstrated ability to define, implement, and maintain compliant software development, execution, and documentation.

Strong autonomy and project ownership: you can drive complex, cross-functional work without waiting to be told what to do next.

Bachelor’s degree in software engineering, computer science, information technology, or a closely related field.

Exceptional interpersonal and collaboration skills - you work as well with lab scientists as you do with software engineers.

Preferred

• Background in molecular diagnostics, oncology, or liquid biopsy (cfDNA, NGS, tumor-informed assays).
• Familiarity with cybersecurity frameworks in a regulated product context (ISO 27001).
• Experience in a Class II or III medical device environment.
• Quality certifications (CQE, CSQE, or equivalent).

Background in molecular diagnostics, oncology, or liquid biopsy (cfDNA, NGS, tumor-informed assays).

Familiarity with cybersecurity frameworks in a regulated product context (ISO 27001).

Experience in a Class II or III medical device environment.

Quality certifications (CQE, CSQE, or equivalent).

WHY JOIN US

This is a high-impact individual contributor role on a team that’s building something that matters. You’ll work directly on systems that power MRD detection for cancer patients - with the autonomy to drive meaningful quality improvements and the backing of both a focused Boulder-based team and Natera’s global infrastructure.

COMPENSATION, BENEFITS & EQUAL OPPORTUNITY

This role offers a competitive annual base compensation of $85,000 - $100,000 commensurate with experience, equity participation, and a comprehensive benefits package including:

• Medical, dental, and vision
• Flexible PTO and paid holidays
• Parental leave
• 401(k) with company match

Medical, dental, and vision

Flexible PTO and paid holidays

Parental leave

401(k) with company match

You will be working on interesting problems with extremely high impact. We promote the professional development of our teams and encourage upward mobility within the company for high performing employees. Foresight Diagnostics 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.

Ready to make an impact in cancer diagnostics?

Apply below - we’d love to hear from you.