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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 capabilities.
As Technical Program Manager for AI Medical Devices, you will coordinate end-to-end execution of Prenuvo's AI-enabled medical-device programs. You'll work across AI Research, Engineering, Systems Engineering, Product, Quality, Regulatory, and Clinical teams to translate technically complex initiatives into clear, executable programs.
Key responsibilities include:
- Program coordination: support project planning, scheduling, and progress tracking for multiple AI device programs
- Cross-functional alignment: collaborate with AI/ML engineers, systems engineers, regulatory affairs, product teams, and clinical operations to keep deliverables synchronized
- Documentation management: set up and maintain project documentation in Jira and other tools, track milestones, and ensure design control and regulatory deliverables are current
- Quality and compliance: support regulatory submissions (510(k), IDE, Health Canada) and plan/execute design control reviews with clear summaries and follow-ups
- Reporting and communication: facilitate status reporting, communicate risks and dependencies to program teams and stakeholders
- Continuous improvement: identify process gaps and contribute ideas to improve collaboration, documentation flow, and delivery efficiency
You'll help Prenuvo's AI and device teams increase capacity to develop and evolve the product portfolio by making complex work more structured and scalable.
Required: 5+ years in Technical Program Management, Technical Project Management, Engineering Program Management, or medical-device product development; 2+ years with regulated medical devices, SaMD, digital health, or similarly regulated clinical technology; experience coordinating multidisciplinary technical programs from development through verification/validation and launch; strong technical fluency working credibly with software engineers, systems engineers, AI/ML researchers, and technical product leaders; familiarity with ML development concepts (datasets, model performance, validation, inference, deployment, monitoring); working knowledge of regulated medical-device development practices (design controls, risk management, verification/validation, change control, post-market processes); experience with FDA and/or Health Canada regulated products.
Preferred: familiarity with ISO 13485, ISO 14971, and IEC 62304; experience with AI/ML-enabled medical devices or SaMD; experience coordinating clinical validation or clinical-performance evaluation; excellent program planning, dependency management, and risk management skills; exceptional communication ability across specialized technical disciplines; comfort in fast-moving environments where scaling processes are still being built.
Note: This role does not provide visa sponsorship. Applicants must be legally authorized to work in Canada or the USA at time of hire and must not require employer sponsorship.
