About The Position

At Roche, we foster a culture where individuality is embraced, and diverse qualities are valued. Our environment encourages personal expression, open dialogue, and genuine connections, ensuring everyone feels accepted and respected. This allows for personal and professional growth, contributing to our mission to prevent, stop, and cure diseases and ensure universal access to healthcare. Roche/GenMark Diagnostics is at the forefront of revolutionizing patient care through high-value, simple-to-perform, and clinically relevant multiplex molecular diagnostics, particularly for infectious disease testing. We aim to enhance patient outcomes, improve laboratory efficiency, and reduce overall healthcare costs with rapid, sample-to-answer solutions. We are seeking a Lead Software Development in Test (SDET) to spearhead the next generation of our automated verification strategy. This is a dynamic 'Player-Coach' role requiring a blend of hands-on framework development and leadership of a dedicated team of Software Quality Engineers. The Lead SDET will drive the technical advancement of our testing capabilities for FDA-regulated diagnostic instruments, championing automation by architecting robust C#/.NET test harnesses, integrating them into modern CI/CD pipelines, and mentoring the team to ensure high-velocity, high-quality releases.

Requirements

  • Bachelor’s Degree in Computer Science, Computer Engineering, or related technical discipline.
  • 8+ years of software engineering or SDET experience.
  • Demonstrated coding experience.
  • 3+ years of leadership experience in a team lead/manager role.
  • Experience supervising a team of Software Quality Engineers.
  • Strong Coding Ability: Deep proficiency in C#/.NET. 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.
  • CI/CD Ops: Experience configuring build pipelines specifically in tools like Azure DevOps (ADO), Jenkins, or GitHub Actions.

Nice To Haves

  • Demonstrated experience transforming a manual testing team into an automation-first team is highly preferred.
  • Experience working in an FDA-regulated environment.
  • Hardware Integration: Experience with hardware-in-the-loop (HiL) testing or testing against physical sensors is highly preferred.
  • Demonstrated experience working in the medical device industry.
  • Demonstrated interest to modernize workflows and show teams "the art of the possible" with automation.
  • Ability to work closely with Software Developers, Program Managers, and Quality Assurance to have effective collaboration between "Dev" and "SQA."
  • Ability to articulate quality risks and technical concepts to non-technical stakeholders.
  • Strong communication skills including the ability to communicate with all levels within the organization; hands-on, self-directed, organized, conscientious.
  • Strong problem-solving, judgment and decision-making skills; ability to think and work both tactically and strategically to meet financial and operational needs for GenMark’s business.
  • Strong time management and organizational skills in a dynamic, continually changing environment; 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.
  • Ability to work effectively, exhibit a professional manner and establish constructive working relationships.
  • Excellent written and verbal communication skills and technical documentation.

Responsibilities

  • 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.
  • 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, 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.
  • 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.
  • 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.
  • Identify and automate "High-Value/Low-Effort" manual tests first to rapidly buy the team breathing room and accelerate feedback cycles.

Benefits

  • A discretionary annual bonus may be available based on individual and Company performance.
  • Benefits detailed at the link provided below.
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