Lead Software Development Engineer in Test

GenMark Diagnostics is seeking a Lead SDET to 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 (40%)

• 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#, Selenium, 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: Evaluate and select the right tools for performance profiling, load testing, and security scanning to ensure comprehensive coverage.

Team Management & Mentorship (40%)

• 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.

Regulatory & Process Compliance (20%)

• 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.

• Bachelor’s Degree in Computer Science, Computer Engineering, or related technical discipline.

• 8+ years of software engineering or SDET experience (Must have hands-on coding experience).

• 3+ years of leadership experience (Team Lead or Manager).

• Experience transforming a manual testing team into an automation-first team is highly preferred.

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., Selenium WebDriver, 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 in tools like Azure DevOps, Jenkins, or GitHub Actions.

• Regulated Environment: Experience working in an FDA-regulated environment is a strong plus.

Soft Skills

• Change Agent: A passion for modernizing workflows and showing teams “the art of the possible” with automation.

• Collaborative: Ability to work closely with Software Developers, Program Managers, and Quality Assurance to bridge the gap between “Dev” and “QA.”

• Communication: Strong ability to articulate quality risks and technical concepts to non-technical stakeholders.

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.