Lead SQE (Software Quality Engineering Manager )

Roche; Carlsbad (CA); On-site; USD 121,000 - 225,000; Full time

Job summary

Roche in Carlsbad, CA is seeking a Lead SDET/SQE Manager to architect automated verification for FDA-regulated diagnostics. You will build C#/.NET test harnesses, mentor engineers, and define the automation strategy to accelerate high-quality releases.

This onsite role requires 8+ years in software testing or SDET, 3+ years leading teams, and experience with C#, NUnit/xUnit, SpecFlow, and Azure DevOps. You will bridge Software, Hardware, and SQA to enable rapid, reliable product deliveries.

Qualifications

• Bachelor's Degree in Computer Science, Computer Engineering, or related field.
• 8+ years of software engineering or SDET experience.
• 3+ years leading software test engineers with coaching experience.
• Hands-on experience building automated test frameworks in C#/.NET.
• Experience in FDA-regulated environments (ISO 13485, 21 CFR Part 820) is preferred.

Responsibilities

• Lead and mentor a team of Software Quality Engineers, guiding automation adoption.
• Establish high standards for test code quality and maintainability.
• Architect and implement automated test frameworks for Windows desktop software and hardware interfaces.
• Collaborate with Regulatory, Quality, Software, and Hardware teams to ensure compliant, rapid releases.

Skills

SDET experience

Leadership experience

C# automation

Education

Bachelor's Degree in CS/CE

Tools

NUnit

xUnit

SpecFlow

Moq

Azure DevOps

Job description

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 / GenMark 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 DevOps CI/CD pipelines
• Modernize Quality Tooling: Work with modern C# tooling (NUnit/xUnit, SpecFlow/BDD, Moq) and establish automated vulnerability and code quality checks in line with modern FDA cybersecurity guidelines.
• RegulatoryOversight: Partner with Regulatory and Quality teams to validate test automation tools in compliance with FDA 21 CFR Part 820 and ISO 13485 standards.

Manager Responsibilities

• 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.

Who You Are

• 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 SpecFlow.
• You have experience integrating static/dynamic security testing (SAST/DAST) into Azure DevOps 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 GenMark'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 d