About the role

Technical Program Manager coordinating AI-enabled medical-device programs at Prenuvo, a proactive healthcare company. Integrating engineering, validation, quality, regulatory, launch, and post-market execution.

Responsibilities

Support project planning, scheduling, and progress tracking for multiple AI device programs
Collaborate with AI/ML engineers, systems engineers, regulatory affairs, product teams, and clinical operations to synchronize deliverables
Set up and maintain project documentation in Jira and other tools
Track milestones and ensure design control and regulatory deliverables are up to date
Support readiness for regulatory submissions such as 510(k), IDE, and Health Canada
Plan and execute design control design reviews, including clear summaries and follow-ups
Facilitate reporting and communicate project status, risks, and dependencies to program teams and stakeholders
Identify process gaps and improve collaboration, documentation flow, and delivery efficiency
Coordinate product development, model development, systems engineering, validation, quality, regulatory readiness, launch, change management, and post-market activities

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 ability to work credibly with software engineers, systems engineers, AI/ML researchers, and technical product leaders
Familiarity with machine-learning development concepts including datasets, model performance, validation, inference, deployment, and production monitoring
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
Familiarity with 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
Successful candidates must undergo a background check
Applicants must be legally authorized to work in Canada or the USA at the time of hire and must not require employer sponsorship for a work visa, current or future

Whole-body scans as part of employee benefits
Growth opportunities and professional development
Weekly team gatherings to connect, share, and socialize
Flexible vacation policy
Comprehensive health, dental, and vision benefits
Mental Health coverage
Eligible Canadian employees: access to RRSP and TFSA retirement savings plans with immediate, optional enrollment; no matching contributions currently offered