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Senior Software Verification and Validation Engineer

Remote Full-time $145K/yr - $175K/yr

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Experience Level

Senior

Qualifications

Qualifications:Proven experience in software verification and validation, particularly in a bioinformatics or computational biology context. Strong understanding of regulatory frameworks, including IEC 62304 and ISO 13485.Demonstrated ability to manage complex testing strategies and protocols. Excellent communication skills to facilitate collaboration across interdisciplinary teams. Detail-oriented mindset with a focus on quality assurance and continuous improvement.

About the job

Location: Boulder, CO · Remote with required travel

As a Senior Software Verification and Validation Engineer at Foresight Diagnostics, part of Natera, you will play a crucial role in ensuring that every software component interacting with MRD results is rigorously verified and validated. We seek an expert who possesses a deep understanding of bioinformatics pipelines coupled with the regulatory knowledge to uphold the integrity of test cases, protocols, and traceability matrices.

ABOUT FORESIGHT DIAGNOSTICS

Foresight Diagnostics is at the forefront of molecular diagnostics, specializing in non-invasive cancer detection through advanced cell-free DNA liquid biopsy technologies. Our innovative methods, initially developed at Stanford University, are designed to identify smaller tumors at earlier stages, enabling tailored treatment plans for cancer patients.

Positioned at the convergence of molecular biology, bioinformatics, and next-generation sequencing (NGS), we transform rigorous scientific research into solutions that have a real clinical impact. Following our acquisition by Natera, we combine the agility of a startup with the extensive resources of a leader in cell-free DNA testing, making this an exhilarating time to join our mission-driven team.

ROLE PURPOSE

Our diverse software portfolio includes bioinformatics pipelines, reagent quality control systems, liquid handling automation, LIMS/LIS integrations, and NGS analysis tools. Each component is subject to stringent regulatory requirements under IEC 62304 and ISO 13485, necessitating a meticulous approach to verification and validation that meets clinical diagnostics standards.

This senior individual contributor role requires you to establish the V&V strategy for device software, oversee the scheduling and prioritization of testing endeavors, and act as the quality and engineering liaison among bioinformatics, software, and laboratory teams. A solid background in bioinformatics or computational biology is essential, as this position does not allow for on-the-job learning of the domain.

About Foresight Diagnostics, Inc.

Foresight Diagnostics is a pioneering molecular diagnostics firm dedicated to advancing non-invasive cancer detection through cutting-edge, cell-free DNA liquid biopsy technologies. Our unique methodologies, originally conceived at Stanford University, empower the early detection of smaller tumors and facilitate more personalized treatment strategies for cancer patients. We combine the innovative spirit of a startup with the extensive reach of a global leader, Natera, making our work impactful and significant in the field of medical diagnostics.

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