Lead SDET (Software Engineering Manager, Test Automation Lead)

Roche / GenMark Diagnostics’ mission is to revolutionize patient care by providing high-value, simple-to-perform, and clinically relevant multiplex molecular diagnostics., Roche/Genmark Diagnostics is seeking a Software Engineering Manager, Test Automation Lead to join our team. 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 “Player-Coach” role where you will balance hands-on framework development with the leadership of a dedicated team of Software Quality Engineers.

You will 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.

Supervisory Responsibilities

• Technical Mentorship: Act as the technical anchor for the SW Quality team. Mentor Quality Engineers on coding best practices, automation scripting, and source control management.
• Team Growth: Foster a collaborative environment where manual testing expertise is complemented by growing technical skills. Lead code reviews for test scripts to ensure they meet production-quality standards.
• Resource Management: Balance hands-on coding (the “Player”) with team leadership (the “Coach”). Align team activities with the software roadmap, ensuring that verification activities happen in parallel with development rather than lagging behind.

The Opportunity

Automation Architecture & Technical Leadership

• Automation Optimization & Rapid Feedback: Lead initiatives to streamline testing processes and accelerate delivery cycles. Strategically prioritize high-impact, quick-win automation to deliver immediate value, free up team bandwidth, and establish fast, reliable feedback loops.
• Framework Design: Design and build scalable, maintainable test frameworks (C#, Playwright, Appium) to unify UI and backend testing logic using advanced object-oriented practices.
• Hardware & Integration Testing: Architect strategies for complex Hardware-in-the-Loop (HiL) testing, ensuring seamless software interactions with diagnostic instruments and sensors.
• CI/CD & Security: Partner with DevOps to embed automated suites into Azure pipelines. Drive “shift-left” security by automating SAST/DAST analysis to meet modern FDA cybersecurity guidelines.
• Modernization & Tooling: Own the tech stack. Evaluate and modernize tools for performance and security profiling, actively deprecating legacy debt to ensure comprehensive, future-proof test coverage.

Regulatory & Process Excellence

• Regulatory Partnership: Partner with Regulatory Affairs to validate testing tools, ensuring rigorous compliance with industry standards.
• Modernized Validation: Update Master V&V Plans to automate evidence generation, streamlining compliance with FDA 21 CFR Part 820 and ISO 13485.
• Data-Driven Quality: Track key metrics (e.g., Defect Density, Automation Coverage) to provide actionable insights and drive continuous quality improvement.
• Risk-First Strategy: Champion safety-critical workflows by embedding software hazard analysis (FMEA) directly into the automation strategy.

• 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 demonstrated coding experience
• You have 3+ years of leadership experience in a team lead/manager role. You have experience supervising a team of Software Quality Engineers.
• You have demonstrated experience transforming a manual testing team into an automation-first team is highly preferred.

Required Technical Skills:

• Mastery of C#/.NET: You have demonstrated ability to write production-grade, scalable code leveraging modern .NET features (async/await, RESTful APIs, and Moq/dependency injection).
• Framework Architect: You have demonstrated experience building robust automation frameworks from the ground up, utilizing Playwright, Appium, and NUnit/xUnit to drive comprehensive end-to-end testing.
• Engineering Methodology: You have demonstrated the ability to embed quality early by implementing TDD or BDD (SpecFlow) practices that bridge the gap between development and QA.
• Hardware Integration: You have demonstrated experience with hardware-in-the-loop (HiL) testing or sensor-driven validation is highly preferred.
• CI/CD Expertise: You have demonstrated experience optimizing the delivery by configuring and maintaining build pipelines in Azure DevOps, Jenkins, or GitHub Actions.

Preferred:

• You have experience working in an FDA-regulated environment
• 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.

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.