Key Responsibilities
• Lead the architecture and integration of a digital pathology platform enabling remote review of cytology slides.
• Define and implement digitization workflows using microscopes and smart devices for consistent, scalable image capture across laboratory environments.
• Design and oversee a high-resolution digital slide viewing system, enabling efficient remote review through zoomable image navigation and reliable performance across variable bandwidth conditions.
• Select, validate, and standardize smart device and imaging configurations for deployment across global diagnostic labs, with priority for LMICs (low- and middle-income countries).
• Architect and manage cloud infrastructure, data pipelines, and cybersecurity frameworks to ensure system performance, scalability, and compliance.
• Establish and implement clinical workflows, including case management, multi-step review processes, and audit trails.
• Ensure compliance with HIPAA, GDPR, FDA, CE-IVDR, and WHO standards.
• Lead the development and maintenance of regulatory documentation and technical files for global submissions.
• Build and lead a multidisciplinary technology organization, including engineering, infrastructure, and data systems.
• Serve as the primary technical interface with partners, regulators, and investors, supporting diligence, validation, and commercialization.
Regulatory Responsibilities
• Prepare and support FDA pathways (510(k), De Novo, LDT)
• Support CE-IVDR readiness, including technical documentation and risk management
• Align platform architecture and workflows with HIPAA/GDPR compliance frameworks
• Support WHO prequalification and global procurement requirements
• Maintain audit-ready technical documentation in collaboration with quality and compliance teams
Qualifications
• 10+ years of experience in digital pathology, medical imaging, or regulated healthcare technology
• Proven experience building and scaling clinical-grade software platforms
• Strong understanding of cloud architecture, data security, and distributed systems
• Experience with regulatory frameworks (FDA, CE, HIPAA, GDPR) and audit-ready systems
• Hands-on experience integrating hardware and software systems (e.g., microscopy, imaging devices)
• Demonstrated leadership in cross-functional technical teams
• Strong communication skills and ability to collaborate with clinical, regulatory, and business stakeholders
• Willingness to be on-site in Southern Nevada
What We Offer
• Competitive, incentivized compensation package
• Opportunity to build and own a first-of-its-kind digital diagnostic platform
• Direct impact on global health outcomes, expanding access to life-saving cancer screening
• A role where technical excellence and mission-driven work converge at scale
We are an innovative healthcare organization focused on transforming women's health through accessible, high-impact solutions. Our work spans clinical, operational, and strategic initiatives with global reach.
We are a growth-stage organization scaling with private equity backing, building toward a top-tier, enterprise-level operation. While we are not yet a fully built-out corporate structure, we are moving quickly in that direction
