Lead SQE (Software Quality Engineering Manager)

F. Hoffmann-La Roche AG; Carlsbad (CA); On-site; USD 135,000 - 225,000; Full time

Job summary

GenMark Diagnostics, now part of Roche Group, seeks a Lead SDET/SQE Manager in Carlsbad, CA to architect robust C# automation and mentor a quality engineering team in an FDA-regulated setting. You will advance automated verification, integrate tools into Azure DevOps pipelines, and collaborate across software and hardware groups.

The onsite role in Carlsbad requires 8+ years in software testing, 3+ years of leadership, and experience with HiL, SpecFlow, and CI/CD tooling.

Qualifications

• Bachelor’s Degree in Computer Science, Computer Engineering, or related technical discipline.
• 8+ years of software engineering or SDET experience.
• 3+ years leading or managing software test engineers with coaching experience.
• Hands-on experience building automated test frameworks from scratch in C# (modern .NET, async programming, and API/UI integration).
• Experience automating Windows desktop applications and testing software that interacts with hardware/sensors.
• Experience in FDA-regulated environments (ISO 13485, 21 CFR Part 820, IEC 62304).
• Preferred: hardware-in-the-loop testing, SpecFlow, SAST/DAST, Azure DevOps pipelines.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead & mentor a team of Software Quality Engineers to adopt automation-first practices.
• Establish high standards for test code quality, maintainability, and design patterns.
• Bridge between Software Development, Hardware Engineering, and SQA to enable parallel verification with development.

Skills

C# automation

Automation leadership

SDET

Windows desktop testing

API/UI automation

Async programming

SpecFlow

SAST/DAST

Azure DevOps

Team leadership

Education

Bachelor's degree in Computer Science, Computer Engineering, or related

Tools

SpecFlow

Azure DevOps

NUnit/xUnit

Moq

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

(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 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 determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

WORK ENVIRONMENT The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment. While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

Who we are GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Acreditamos ser necessário oferecer soluções médicas agora – mesmo quando desenvolvemos inovações para o futuro. Nosso compromisso é transformar a vida dos pacientes. Temos coragem para decidir e agir. Acreditamos também que bons negócios significam um mundo melhor. É para isso que trabalhamos diariamente. Temos compromissos com o rigor científico, com a ética e com o acesso a inovações médicas para todos. Fazemos isso hoje para construir um amanhã melhor. Temos orgulho de quem somos, do que fazemos e de como fazemos. Somos muitos, trabalhando como um em todo o mundo. Somos Roche.