Technical Program Manager – AI Medical Devices

About the role

The Technical Program Manager, AI Medical Devices at Prenuvo is responsible for coordinating the end-to-end execution of AI-enabled medical-device programs. This role involves working across various teams including AI/ML engineers, systems engineering, regulatory affairs, product teams, and clinical operations to ensure that technically complex medical-device initiatives are turned into clear, executable programs. The position also focuses on connecting product development, model development, systems engineering, validation, quality, regulatory readiness, launch, change management, and post-market activities into one integrated plan. This role helps Prenuvo's AI and device teams increase their capacity to develop and evolve their product portfolio.

What You'll Do

• Support project planning, scheduling, and progress tracking for multiple AI device programs.
• Collaborate closely with AI/ML engineers, systems engineers, regulatory affairs, product teams, and clinical operations to keep deliverables synchronized across teams.
• Document and manage project documentation in Jira and other tools, track milestones, and ensure all design control and regulatory deliverables are up to date.
• Support readiness for regulatory submissions (such as 510(k), IDE, Health Canada) and plan/execute design control design reviews, including capturing clear summaries and follow-ups.
• Facilitate reporting and communicate project status, risks, and dependencies to the program team and stakeholders.
• Identify process gaps and contribute ideas to improve collaboration, documentation flow, and delivery efficiency.

What You'll Bring

• 5+ years of experience in Technical Program Management, Technical Project Management, Engineering Program Management, medical-device product development, or a closely related discipline.
• 2+ years working with regulated medical devices, Software as a Medical Device, digital health, or similarly regulated clinical technology.
• Experience coordinating multidisciplinary technical programs from development through verification/validation and launch.
• Strong technical fluency and the ability to work credibly with software engineers, systems engineers, AI/ML researchers, and technical product leaders.
• Familiarity with machine-learning development concepts such as datasets, model performance, validation, inference, deployment, and production monitoring.
• You do not need to be an ML engineer.
• Working knowledge of regulated medical-device development practices, including design controls, risk management, verification and validation, change control, and post-market processes.
• Experience working with Quality and Regulatory teams on FDA and/or Health Canada regulated products.

Nice to Haves

• Familiarity with standards such as ISO 13485, ISO 14971, and IEC 62304 is strongly preferred.
• Experience specifically with AI/ML-enabled medical devices or SaMD is strongly preferred.
• Experience coordinating clinical validation or clinical-performance evaluation is a plus.
• Excellent program-planning, dependency-management, and risk-management skills.
• Exceptional communication and the ability to create clarity across specialized technical disciplines.
• Comfort operating in a fast-moving environment where the processes required to scale are still being built.

Pay

The base salary for this role ranges from $170,000-$200,000 in local currency, depending upon experience and geographic location.

Schedule

Details on the schedule will be provided during the interview process.