Lead SQE (Software Quality Engineering Manager)

About the role

Roche / GenMark Diagnostics’ mission is to revolutionize patient care by providing high-value, simple-to-perform, and clinically relevant multiplex molecular diagnostics. We build rapid, sample-to-answer molecular diagnostic instruments that save lives in critical care settings. In this pivotal leadership role, you will define the vision for automated verification, steering both technical strategy and team development to enhance laboratory efficiency and patient outcomes through rapid, sample-to-answer solutions. This is a high-impact role where you will architect C# automation frameworks and mentor engineers, leading the technical evolution of our testing capabilities for FDA-regulated diagnostic instruments.

Responsibilities

• Technical Architect:
  • Design and build robust test automation frameworks in C# / .NET tailored for Windows desktop software and physical instrument interfaces (Hardware-in-the-Loop).
  • Lead the evolution of quality engineering by transforming manual testing into high-impact, scalable automated suites integrated into Azure DevOps CI/CD pipelines.
  • Modernize quality tooling with modern C# tooling (NUnit/xUnit, SpecFlow/BDD, Moq) and establish automated vulnerability and code quality checks in line with modern FDA cybersecurity guidelines.
  • Partner with Regulatory and Quality teams to validate test automation tools in compliance with FDA 21 CFR Part 820 and ISO 13485 standards.
• Manager Responsibilities:
  • Directly manage and grow a team of Software Quality Engineers, guiding them from manual testing methodologies into modern automation best practices.
  • Establish high standards for test code quality, maintainability, and design patterns across the SQA team.
  • Serve as the technical bridge between Software Development, Hardware Engineering, and SQA to ensure verification happens in parallel with software development.

Requirements

• Bachelor’s Degree in Computer Science, Computer Engineering, or related technical discipline.
• 8+ years of software engineering or SDET experience.
• 3+ years leading or managing software test engineers with a track record of coaching teams through test automation transformations.
• Demonstrated hands-on experience building automated test frameworks from scratch in C# (including modern .NET, async programming, and API/UI integration).
• Demonstrated experience automating Windows Desktop applications and/or testing software that interacts with physical hardware/sensors.
• Experience working in an FDA regulated environment (ISO 13485, 21 CFR Part 820, IEC 62304).

Preferred Qualifications

• Experience with hardware-in-the-loop (HiL) testing or sensor-driven validation.
• Experience with BDD frameworks like SpecFlow.
• Experience integrating static/dynamic security testing (SAST/DAST) into Azure DevOps pipelines.
• Strong communication skills, including the ability to communicate with all levels within the organization.
• Strong problem-solving, judgment, and decision-making skills; ability to think and work both tactically and strategically.
• Strong time management and organizational skills in a dynamic, continually changing environment.

Pay

The expected salary range for this position based in Carlsbad, CA is $121,400 - $225,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

This position qualifies for the benefits detailed at the link provided below.

Work Environment: The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens, and automated equipment. While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.

Schedule

This position is an onsite position based in Carlsbad, CA. (This is not a hybrid role.) Relocation benefits are not being offered for this role.