Technical Architect

Roche/Genmark Diagnostics is seeking a Lead SDET / SQE Manager who loves both building C# automation frameworks and mentoring engineers. In this role, the Software Manager will architect the next generation of our automated verification strategy. 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. You will build C# automation frameworks and mentoring engineers.

This is an opportunity to 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., * Architect Desktop & Hardware Automation: Design and build robust test automation frameworks in C# / .NET tailored for Windows desktop software and physical instrument interfaces (Hardware-in-the-Loop).

• Elevate & Scale Workflows: 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: Work with modern C# tooling (NUnit/xUnit, SpecFlow/BDD, Moq) and establish automated vulnerability and code quality checks in line with modern FDA cybersecurity guidelines.
• RegulatoryOversight: 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:

• Lead & Mentor: Directly manage and grow a team of Software Quality Engineers, guiding them from manual testing methodologies into modern automation best practices.
• Code Reviews & Standards: Establish high standards for test code quality, maintainability, and design patterns across the SQA team.
• Bridge the Gap: Serve as the technical bridge between Software Development, Hardware Engineering, and SQA to ensure verification happens in parallel with software development.

• 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 3+ years leading or managing software test engineers with a track record of coaching teams through test automation transformations.
• You have demonstrated hands-on experience building automated test frameworks from scratch in C# (including modern .NET, async programming, and API/UI integration).
• You have demonstrated experience automating Windows Desktop applications and/or testing software that interacts with physical hardware/sensors
• You have experience working in an FDA regulated environment (ISO 13485, 21 CFR Part 820, IEC 62304).
• You have demonstrated experience transforming a manual testing team into an automation-first team is highly preferred.

Preferred:

• You have demonstrated experience with hardware-in-the-loop (HiL) testing or sensor-driven validation
• You have experience with BDD frameworks like SpecFlow.
• You have experience integrating static/dynamic security testing (SAST/DAST) into Azure DevOps pipelines.
• You have strong communication skills including the ability to communicate with all levels within the organization
• You have strong problem-solving, judgment and decision-making skills; you have the ability to think and work both tactically and strategically to meet financial and operational needs for GenMark’s business
• You have strong time management and organizational skills in a dynamic, continually changing environment; you have the 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., Application Programming Interface (API), Automation, Best Practices, Biotech and Pharmaceutical, Blood-Borne Pathogens, Bridge Building, Clinical Laboratory, Coaching, Coagulation, Code Reviews, Code of Federal Regulations, Communication Skills, Computer Engineering, Computer Science, Continuous Deployment/Delivery, Continuous Integration, Corporate Policies, Cost Control, Design Patterns Programming Methodologies, Desktop Hardware, DevOps, Diabetes, Disease, Disease Prevention and Control, Engineering Management, FDA (Food and Drug Administration), Financial Operations, HIV/AIDS (Acquired Immune Deficiency Syndrome), Hardware Architecture, Hardware Design, Healthcare, Hepatitis, Home Automation, Hospital Systems, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), International Health, Internet Security, Leadership, Legal, Machine Tool, Medical Conditions, Mentoring, Microsoft .NET, Microsoft C# (C Sharp), Microsoft Windows Azure, Microsoft Windows Desktop, Multiplexing, NUnit, Order Processing, Organizational Skills, Patient Care, Presentation/Verbal Skills, Quality Assurance Methodology, Quality Engineering, Quality Management, Regulations, Software Design for Test (SDET), Software Development, Software Engineering, Software Testing, Team Building, Technical Strategy, Test Automation, Test Harness, Test Tools, Testing, Time Management, User Interface/Experience (UI/UX)

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.