Director Software Quality Engineering Jobs in California

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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.