Lead SDET; Software Development Engineer in Test

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.

Roche / Gen Mark Diagnostics is seeking a Lead Software Development in Test (SDET) to architect the next generation of our automated verification strategy. This high‑impact "Player‑Coach" role balances 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 and champion a culture of automation.

• Architect and build scalable, maintainable test automation frameworks using C#, Playwright, Appium, or similar to support UI and backend logic.
• Identify and automate high‑value/low‑effort manual tests to accelerate feedback cycles and reduce manual testing burden.
• Design test strategies for hardware‑in‑the‑loop (HiL) testing and integration with physical diagnostic instruments and sensors.
• Partner with Dev Ops/Architecture teams to integrate automated suites into Azure Dev Ops pipelines and lead automation of vulnerability scanning and static/dynamic analysis (SAST/DAST) for FDA cybersecurity guidelines.
• Evaluate, select, and maintain tooling for performance profiling, load testing, and security scanning while deprecating legacy dependencies.
• Provide technical mentorship to Quality Engineers on coding best practices, automation scripting, and source control management.
• Lead code reviews for test scripts and ensure production‑quality standards.
• Align team activities with the software roadmap, ensuring verification runs in parallel with development.
• Collaborate with Regulatory Affairs to formally validate automated testing tools and support FDA 21
  
  CFRPart
  820 and ISO
  13485 compliance.
• Define and track key quality metrics (e.g., defect density, automation coverage) to drive continuous improvement.
• Participate in software hazard analysis (FMEA) to prioritize safety‑critical workflows.

• Bachelor’s Degree in Computer Science, Computer Engineering, or a related technical discipline.
• 8+ years of software engineering or SDET experience.
• 3+ years of leadership experience in a team‑lead/manager role, including supervising Software Quality Engineers.
• Demonstrated success transforming a manual testing team into an automation‑first organization.
• Strong coding ability in C#/.NET with experience writing production‑quality code and advanced concepts such as async/await and modern .NET Core.
• Experience building automation frameworks from scratch (Playwright, Appium, NUnit/xUnit).
• Experience with Test Driven Development (TDD) or Behavior Driven Development (BDD) (e.g., Spec Flow).
• Experience with hardware‑in‑the‑loop (HiL) testing or testing against physical sensors highly preferred.
• Experience configuring build pipelines in Azure Dev Ops, Jenkins, or Git Hub Actions.
• Strong communication and stakeholder management skills with the ability to articulate quality risks and technical concepts to non‑technical audiences.
• Strong problem‑solving, judgment, decision‑making, and time‑management skills in a dynamic environment.
• Excellent written and verbal communication skills and technical documentation ability.

• Experience in the medical device industry and in FDA‑regulated environments.
• Interest in modernizing workflows and demonstrating automation possibilities to teams.
• Ability to collaborate effectively with Software Developers, Program Managers, and Quality Assurance.

The position is onsite in Carlsbad, CA. The role may involve office and biotechnology laboratory environments, with exposure to hazardous chemicals and automated equipment. The employee may be required to sit, stand, walk, and lift up to 35 pounds.

Salary range: $121,400 – $225,400 (Carlsbad, CA). Additional benefits include a discretionary annual bonus and eligibility for Roche’s benefits package.

Gen Mark (now part of Roche) is an equal‑opportunity employer. We do not discriminate on the basis of veteran status, disability, or any other protected characteristic. Applicants with disabilities may request accommodations during the application process.

For disability accommodations related to the online application process, please complete the Accommodations for Applicants form.