ABOUT GENALYTE

At Genalyte, we’re revolutionizing diagnostic testing to empower a healthier future. Genalyte is a San Diego-based diagnostics company developing the Merlin platform, a novel photonic ring resonator-based system designed to deliver rapid, multiplexed diagnostic results. We believe that timely and accurate health insights shouldn’t be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

WHY WORK FOR US

As a senior leader joining at a pivotal pre-commercial stage, you will have outsized influence on the technical direction and culture of the software engineering organization, with direct partnership with the CTO and visibility to the Board of Directors. Genalyte offers competitive compensation including base salary, equity participation, and comprehensive benefits (health, dental, vision, and Flex Time Off). This is a ground-floor opportunity to shape a high-impact software engineering organization at a company poised to transform diagnostic testing.

POSITION SUMMARY

The Head of Software Engineering is responsible for defining and executing the company’s software engineering strategy in support of Genalyte’s instrument, cloud, and data platforms across the product lifecycle. This leader will build, scale, and mentor high-performing engineering teams while ensuring the delivery of secure, validated, and compliant software systems in an FDA-regulated Class II medical device and CLIA/HIPAA laboratory environment. The Head of Software Engineering will partner closely with Systems Engineering, Hardware, Regulatory Affairs, and Quality Assurance to drive innovation and operational excellence from development through commercial launch.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to:

• Lead the vision, strategy, and execution of Genalyte’s software roadmap aligned with business objectives and regulatory requirements
• Build, manage, and scale high-performing software engineering teams, including hiring, mentoring, performance management, and organizational design
• Oversee the development and maintenance of instrument-embedded software, cloud/SaaS platforms, laboratory information systems (LIMS), data pipelines, and customer-facing applications supporting the Merlin platform
• Ensure software quality, reliability, security, and performance in compliance with FDA 21 CFR Part 820, IEC 62304, CLIA, HIPAA, and other applicable regulatory standards
• Partner with Product Management to translate business and clinical requirements into scalable technical solutions
• Establish and enforce best practices for SDLC, CI/CD, code quality, design controls, documentation, and system architecture in accordance with IEC 62304 software lifecycle requirements
• Lead software verification, validation (V&V), and documentation efforts to support regulatory submissions (510(k), De Novo) and ongoing compliance
• Drive technical decision-making across firmware, instrument software, cloud services, and data pipeline teams in partnership with Systems Engineering and Hardware
• Evaluate and integrate emerging technologies including AI/ML for diagnostic algorithms, data analysis, and operational efficiency
• Develop and manage departmental budgets, vendor relationships, and technology investments; present engineering budget and resource plans to executive leadership and the Board of Directors
• Provide regular reporting on engineering performance, risks, and delivery status to executive leadership

ADDITIONAL FUNCTIONS & RESPONSIBILITIES

• Represent Software Engineering in audits, inspections, and customer or partner meetings as needed
• Champion innovation, continuous improvement, and engineering culture across the organization
• Contribute to due diligence processes, investor presentations, and strategic planning as a member of the technical leadership team

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS & ABILITIES

• Bachelor’s degree in Computer Science, Engineering, or related field required; advanced degree preferred
• Minimum of 10 years of progressive software engineering experience, including 5+ years in a leadership role
• Prior experience in medical devices, diagnostics (IVD), or healthcare technology in a regulated environment required
• Experience with FDA regulatory submissions (510(k), De Novo, PMA) and software as a medical device (SaMD) or software in a medical device (SiMD) highly desirable
• Familiarity with IEC 62304 (software lifecycle for medical devices) and ISO 13485 quality management systems
• Proven track record of building and scaling high-performing engineering organizations
• Deep understanding of cloud architectures, enterprise software, cybersecurity, and data systems
• Strong knowledge of software development methodologies, validation processes, and regulatory compliance
• Excellent leadership, communication, and stakeholder management skills
• Strategic thinker with the ability to execute in a fast-paced, pre-commercial environment

TECHNICAL KNOWLEDGE

Modern development toolchains, cloud platforms (AWS, GCP, or Azure), containerization and orchestration (Docker, Kubernetes), CI/CD pipelines, and DevOps practices. Familiarity with embedded systems development environments.

TRAVEL REQUIREMENTS

Minimal; occasional travel for industry conferences, partner meetings, or regulatory interactions (<10%).

PHYSICAL REQUIREMENTS & WORK ENVIRONMENT

This is a primarily office-based role in San Diego, CA. Occasional visits to laboratory and engineering environments may be required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

COMPENSATION

The base salary range for this role is $200,000 – $245,000 per year. Individual pay may vary based on job-related skills, experience, and relevant education or training. In addition to base salary, this role includes meaningful equity participation, eligibility for the annual target bonus plan, and a comprehensive benefits package (health, dental, vision, and Flex Time Off).

EQUAL EMPLOYMENT OPPORTUNITY

Genalyte, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.