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Prenuvo is transforming healthcare from reactive sick-care to proactive health management through award-winning whole-body MRI scans combined with AI-enabled analysis. The company operates a global network of clinics and is building an integrated stack of optimized hardware, software, and increasingly AI to detect health issues earlier.
You will serve as Technical Program Manager for Prenuvo's AI-enabled medical-device initiatives, coordinating end-to-end execution across multiple complex programs. Your primary responsibility is to connect product development, AI/ML model development, systems engineering, validation, quality assurance, regulatory compliance, clinical operations, and post-market activities into one integrated, executable plan.
Key responsibilities include: supporting project planning, scheduling, and progress tracking for multiple AI device programs; collaborating with AI/ML engineers, systems engineers, regulatory affairs, product teams, and clinical operations to keep deliverables synchronized; setting up and maintaining project documentation in Jira and other tools while tracking milestones and regulatory deliverables; supporting regulatory readiness for submissions (510(k), IDE, Health Canada) and design control reviews; facilitating status reporting and communicating risks and dependencies to stakeholders; and identifying process improvements to enhance collaboration and delivery efficiency.
You will need 5+ years in Technical Program Management, Technical Project Management, Engineering Program Management, or medical-device product development, plus 2+ years working with regulated medical devices, Software as a Medical Device, or digital health. Strong technical fluency with software engineers, systems engineers, AI/ML researchers, and product leaders is essential. You should have familiarity with machine-learning development concepts (datasets, model performance, validation, inference, deployment, monitoring) and working knowledge of regulated medical-device development practices including design controls, risk management, verification/validation, and change control. Experience with FDA and/or Health Canada regulated products is required.
Preferred qualifications include familiarity with ISO 13485, ISO 14971, and IEC 62304 standards; specific experience with AI/ML-enabled medical devices or SaMD; clinical validation coordination experience; and comfort operating in fast-moving environments where processes are still being built.
