Senior Software V&V Engineer, Remote

Picture a clinician receiving a critical MRD result, a piece of information that profoundly impacts a patient's treatment journey. For every data point on that report, every single line of software involved must meet the most stringent verification and validation standards. That vital responsibility rests with our V&V team at Foresight Diagnostics, now proudly part of Natera. We are actively seeking a Senior Software V&V Engineer. Someone who truly understands bioinformatics pipelines, capable of dissecting and testing them with unwavering rigor, and who brings the regulatory expertise to ensure every test case, protocol, and traceability matrix stands firm under intense scrutiny. This fully remote, worldwide opportunity offers a chance to directly contribute to life-changing diagnostics.

Overview

Natera, through its Foresight Diagnostics division, is at the forefront of revolutionizing cancer detection with highly sensitive liquid biopsy technologies. Our proprietary methods, originally developed at Stanford University, aim to find smaller tumors earlier and enable more personalized treatment strategies for patients with cancer. This role sits at the heart of translating cutting-edge science into reliable clinical solutions, ensuring the integrity of the software that powers these diagnostics. As a Senior Software V&V Engineer, you will be instrumental in validating our complex bioinformatics pipelines, working at the exciting intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS).

Key Responsibilities

In this pivotal role, your key responsibilities will encompass:

Design, develop, and execute comprehensive software verification and validation plans for intricate bioinformatics pipelines.
Rigorously test complex algorithms and data processing workflows, ensuring critical accuracy for clinical diagnostic results.
Create and maintain detailed V&V documentation, including robust test cases, thorough protocols, and clear traceability matrices, all adhering to strict regulatory requirements.
Collaborate closely with bioinformatics, software development, and quality assurance teams throughout the entire product lifecycle.
Proactively identify, analyze, and precisely document software defects, working seamlessly with development teams to ensure their timely and effective resolution.
Contribute actively to the continuous improvement of V&V processes, methodologies, and best practices.
Ensure all V&V activities consistently comply with relevant regulatory standards, such as CLIA, CAP, and FDA guidelines.

Requirements

To thrive in this position, you will ideally bring:

Extensive experience as a Software V&V Engineer, preferably gained within a highly regulated environment like IVD, medical devices, or pharmaceuticals.
A deep and demonstrable understanding of bioinformatics pipelines, including next-generation sequencing (NGS) data processing and analysis.
Proven ability to design and implement robust and effective test strategies for complex software systems.
Strong knowledge of regulatory requirements for software in clinical diagnostics, including CLIA, CAP, and FDA 21 CFR Part 820, along with GxP principles.
Proficiency in scripting languages such as Python or R, coupled with practical experience using version control systems like Git.
Familiarity with cloud computing environments (e.g., AWS, Azure, GCP) and containerization technologies (e.g., Docker) is a significant advantage.
Exceptional analytical, problem-solving, and professional communication skills, both written and verbal.
A Bachelor's or Master's degree in Bioinformatics, Computer Science, Electrical Engineering, or a closely related scientific or engineering discipline.

What You'll Gain

The profound satisfaction of contributing directly to life-saving cancer diagnostics and patient care.
An unparalleled opportunity to work with cutting-edge liquid biopsy technology and advanced bioinformatics platforms.
The chance to be part of a dynamic, mission-driven team dedicated to scientific rigor and significant patient impact.
Accelerated professional growth and development within a rapidly evolving and innovative biotech landscape.
A fully remote work environment, offering unparalleled flexibility and a strong emphasis on work-life balance, from anywhere in the world.
A competitive compensation package and comprehensive benefits designed to support your well-being.