Summary: Lead the architecture, integration, and regulatory compliance of a digital pathology platform for remote cytology review, building and leading a multidisciplinary technology organization. Highlights: 1. Lead digital pathology platform architecture and integration 2. Drive global health outcomes with accessible diagnostic solutions 3. Build and lead a multidisciplinary technology organization 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
Craigslist · HR
Craigslist · HR
