Lead SDET; Software Development Engineer in Test

Position

Roche / Gen Mark 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.

• 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 Dev Ops/Architecture team to integrate automated suites into Azure Dev Ops 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.

• 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.

• 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.

This is an onsite position based in Carlsbad, CA. (This is not a hybrid role.)

Relocation benefits are not being offered for this role.

• 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…