Lead Software Development Engineer in Test

Roche•Carlsbad, NM

About The Position

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 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.

Requirements

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).
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.
CI/CD Ops: Experience configuring build pipelines in tools like Azure DevOps, Jenkins, or GitHub Actions.
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.

Nice To Haves

Experience transforming a manual testing team into an automation-first team is highly preferred.
Hardware Integration: Experience with hardware-in-the-loop (HiL) testing or testing against physical sensors is highly preferred.
Regulated Environment: Experience working in an FDA-regulated environment is a strong plus.

Responsibilities

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.
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.
Design test strategies that account for hardware-in-the-loop (HiL) testing and software interactions with physical diagnostic instruments and sensors.
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.
Evaluate and select the right tools for performance profiling, load testing, and security scanning to ensure comprehensive coverage.
Act as the technical anchor for the SW Quality team.
Mentor Quality Engineers on coding best practices, automation scripting, and source control management.
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.
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.
Collaborate closely with Regulatory Affairs (RA) to formally validate automated testing tools, ensuring they meet strict regulatory compliance standards.
Enhance Master V&V Plans to support automated evidence generation, ensuring strict compliance with FDA 21 CFR Part 820 and ISO 13485 standards.
Define and track key quality metrics (e.g., Defect Density, Automation Coverage) to drive continuous improvement and transparency.
Participate in software hazard analysis (FMEA) to ensure safety-critical workflows are prioritized in the automation strategy.