Lead SQE (Software Quality Engineering Manager

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

Join Roche, where every voice matters. The Position Roche / Gen Mark Diagnostics’ mission is to revolutionize patient care by providing high-value, simple-to-perform, and clinically relevant multiplex molecular diagnostics. We build rapid, sample-to-answer molecular diagnostic instruments that save lives in critical care settings. Roche/Genmark Diagnostics is seeking a Lead SDET / SQE Manager who loves both building C# automation frameworks and mentoring engineers.

In this role, the Software Manager will architect the next generation of our automated verification strategy. In this pivotal leadership role, you will define the vision for automated verification, steering both technical strategy and team development to enhance laboratory efficiency and patient outcomes through rapid, sample-to-answer solutions. This is a high-impact role. You will build C# automation frameworks and mentoring engineers.

This is an opportunity to lead the technical evolution of our testing capabilities for FDA-regulated diagnostic instruments. Your mandate is to champion a culture of automation—architecting robust C#/.NET test harnesses, integrating them into modern CI/CD pipelines, and mentoring the team to ensure high-velocity, high-quality releases.

The Opportunity Technical Architect:
Architect Desktop & Hardware Automation:
Design and build robust test automation frameworks in C# / .NET tailored for Windows desktop software and physical instrument interfaces (Hardware-in-the-Loop). Elevate & Scale Workflows:
Lead the evolution of quality engineering by transforming manual testing into high-impact, scalable automated suites integrated into Azure Dev Ops CI/CD pipelines Modernize Quality Tooling:
Work with modern C# tooling (NUnit/xUnit, Spec Flow/BDD, Moq) and establish automated vulnerability and code quality checks in line with modern FDA cybersecurity guidelines. Regulatory Oversight:
Partner with Regulatory and Quality teams to validate test automation tools in compliance with FDA 21 CFR Part 820 and ISO 13485 standards.

Lead & Mentor:
Directly manage and grow a team of Software Quality Engineers, guiding them from manual testing methodologies into modern automation best practices. Code Reviews & Standards:
Establish high standards for test code quality, maintainability, and design patterns across the SQA team. Bridge the Gap:
Serve as the technical bridge between Software Development, Hardware Engineering, and SQA to ensure verification happens in parallel with software development.

(Required) You have a Bachelor’s Degree in Computer Science, Computer Engineering, or related technical discipline. You have 8+ years of software engineering or SDET experience You have 3+ years leading or managing software test engineers with a track record of coaching teams through test automation transformations. You have demonstrated hands-on experience building automated test frameworks from scratch in C# (including modern .NET,

async programming, and API/UI integration). You have demonstrated experience automating Windows Desktop applications and/or testing software that interacts with physical hardware/sensors You have experience working in an FDA regulated environment (ISO 13485, 21 CFR Part 820, IEC 62304). You have demonstrated experience transforming a manual testing team into an automation-first team is highly preferred. Preferred:
You have demonstrated experience with hardware-in-the-loop (HiL) testing or sensor-driven validation You have experience with BDD frameworks like Spec Flow. You have experience integrating static/dynamic security testing (SAST/DAST) into Azure Dev Ops pipelines. You have strong communication skills including the ability to communicate with all levels within the organization You have strong problem-solving, judgment and decision-making skills; you have the ability to think and work both tactically and strategically to meet financial and operational needs for Gen Mark’s business You have strong time management and organizational skills in a dynamic, continually changing environment;

you have the ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals.

This position is an onsite position based in Carlsbad, CA. (This is not a hybrid role.) Relocation benefits are not being offered for this role. The expected salary range for this position based in Carlsbad, CA is $121,400 - $225,400. Actual pay will be determined based on…