Lead SDET (Software Development Engineer in Test)

Roche / GenMark Diagnostics' mission is to revolutionize patient care by providing high-value, simple-to-perform, and clinically relevant multiplex molecular diagnostics, specifically targeting infectious disease testing. We aim to improve patient outcomes, enhance laboratory efficiency, and reduce total cost-of-care through rapid, sample-to-answer solutions., Roche/Genmark Diagnostics is seeking a Lead Software Development in Test (SDET) to join our team. In this role, the Lead SDET will architect the next generation of our automated verification strategy. 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.

The Opportunity

Automation Architecture & Technical Leadership

• Technical Debt Remediation: Act as the specialist in reducing our manual testing burden. Identify and automate "High-Value/Low-Effort" manual tests first to rapidly buy the team breathing room and accelerate feedback cycles.
• Framework Design: Architect and build scalable, maintainable test automation frameworks (using C#, Playwright, Appium, or similar) to support both UI and backend logic, utilizing advanced object-oriented programming.
• Hardware & Integration Testing: Design test strategies that account for hardware-in-the-loop (HiL) testing and software interactions with physical diagnostic instruments and sensors.
• Continuous Integration & Security: Partner with the DevOps/Architecture team to integrate automated suites into Azure DevOps pipelines. Lead the automation of vulnerability scanning and static/dynamic analysis (SAST/DAST) to align with modern FDA cybersecurity guidelines.
• Tooling Selection & Modernization: Evaluate, select, and continuously modernize the right tools for performance profiling, load testing, and security scanning to ensure comprehensive coverage while proactively deprecating legacy testing dependencies.

Team Management & Mentorship

• Technical Mentorship: Act as the technical anchor for the SW Quality team, lead and 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.

Regulatory & Process Compliance

• Tool Validation: Collaborate closely with Regulatory Affairs (RA) to formally validate automated testing tools, ensuring they meet strict regulatory compliance standards.
• V&V Modernization: Enhance Master V&V Plans to support automated evidence generation, ensuring strict compliance with FDA 21 CFR Part 820 and ISO 13485 standards.
• Metrics Driven: Define and track key quality metrics (e.g., Defect Density, Automation Coverage) to drive continuous improvement and transparency.
• Risk Analysis: Participate in software hazard analysis (FMEA) to ensure safety-critical workflows are prioritized in 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
• You have experience working in an FDA-regulated environment

Required Technical Skills:

• Strong Coding Ability: Deep proficiency in C#/.NET. You must be able to write production-quality code and demonstrate an understanding of advanced concepts (e.g., async/await, modern .NET core, RESTful API integration, and mocking frameworks like Moq).
• Framework Experience: Proven experience building automation frameworks from scratch (e.g., Playwright, Appium for UI, NUnit/xUnit for API/Logic).
• Methodology: Explicit experience implementing Test Driven Development (TDD) or Behavior Driven Development (BDD, e.g., SpecFlow) to align engineering and quality teams.
• Hardware Integration: Experience with hardware-in-the-loop (HiL) testing or testing against physical sensors is highly preferred.
• CI/CD Ops: Experience configuring build pipelines specifically in tools like Azure DevOps (ADO), Jenkins, or GitHub Actions.

Preferred:

• You have demonstrated experience working in the medical device industry
• You have a demonstrated interest to modernize workflows and show teams "the art of the possible" with automation.
• You have the ability to work closely with Software Developers, Program Managers, and Quality Assurance to have effective collaboration between "Dev" and "SQA."
• You have the ability to articulate quality risks and technical concepts to non-technical stakeholders.
• You have strong communication skills including the ability to communicate with all levels within the organization; you are hands-on, self-directed, organized, conscientious.
• 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.
• You have the ability to work effectively, exhibit a professional manner and establish constructive working relationships.
• You have excellent written and verbal communication skills and technical documentation

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.