Genalyte is revolutionizing diagnostic testing and needs to define and execute a software engineering strategy to support its clinical, diagnostic, and commercial platforms, ensuring the delivery of secure, high-quality, and compliant software systems in a regulated medical device and laboratory environment.
Requirements
- Deep understanding of cloud architectures, enterprise software, cybersecurity, and data systems
- Strong knowledge of software development methodologies, validation processes, and regulatory compliance
Responsibilities
- Lead the vision, strategy, and execution of Genalyte’s software roadmap aligned with business objectives and regulatory requirements
- 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.
- Provide regular reporting on engineering performance, risks, and delivery status to executive leadership
Other
- Build, manage, and scale high-performing software engineering teams, including hiring, mentoring, performance management, and organizational design
- Manage departmental budgets, vendor relationships, and technology investments
- Represent Software Engineering in audits, inspections, and customer or partner meetings as needed
- Champion innovation, continuous improvement, and engineering culture across the organization
- Excellent leadership, communication, and stakeholder management skills
- Strategic thinker with the ability to execute in a fast-paced, pre-commercial environment
- Prior experience in medical devices, diagnostics, healthcare technology, or other regulated industries strongly preferred
