ABOUT GENALYTE
At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. 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
We believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and generous paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.
POSITION SUMMARY
The Head of Software Engineering is responsible for defining and executing the company’s software engineering strategy in support of Genalyte’s clinical, diagnostic, and commercial platforms. This leader will build, scale, and mentor high-performing engineering teams while ensuring the delivery of secure, high-quality, and compliant software systems in a regulated medical device and laboratory environment. The Head of Software Engineering will partner closely with other R&D functions as well as Regulatory and Quality to drive innovation and operational excellence.
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 cloud-based and on-premise software platforms supporting diagnostics, laboratory operations, data analytics, and customer-facing applications
- Ensure software quality, reliability, security, and performance in compliance with FDA, CLIA, HIPAA, and other applicable regulatory standards
- Partner with Product Management to translate business and clinical requirements into scalable technical solutions
- Establish best practices for SDLC, CI/CD, code quality, documentation, and system architecture
- Lead software validation and documentation efforts to support regulatory filings and compliance.
- Manage departmental budgets, vendor relationships, and technology investments
- 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
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND 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, healthcare technology, or other regulated industries strongly preferred
- 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
The base range for this role is $200,000 - $245,000 per year. Individual pay may vary based on additional factors, including but not limited to, job-related skills, experience, work location, and relevant education or training. In addition to base salary, Genalyte provides generous benefits, equity opportunities, and for some roles, participation in our annual target bonus plan.
Top Skills
What We Do
Genalyte is a tech-enabled, full service CAP accredited and CLIA certified laboratory. We perform the majority of tests with our rapidly deployable mobile laboratory in under 30 minutes. Our central lab handles tests that cannot be performed onsite. All results are run through CloudLab, our proprietary tele-health platform, for quality oversight and monitoring by Clinical Lab Scientists.
Core to our mobile capabilities is the Maverick platform, which has unprecedented serological testing functionality - permitting up to 64 simultaneous immunoassays on whole blood in 15 minutes. The platform achieved FDA clearance in Oct 2019. In these unprecedented times, we have developed a rapid COVID-19 serology test for IgG and IgM antibodies, while simultaneously including flu and other respiratory illnesses for differential diagnosis.
For more information, visit www.genalyte.com.
