Technical Program Manager – AI Medical Devices

Prenuvo

2d • $170,000 - $200,000

About The Position

At Prenuvo, we are on a mission to flip the paradigm from reactive “sick-care” to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience across our domestic and global clinics, have allowed us to lead the change against “we caught it too late again".
We are hiring a Technical Program Manager, AI Medical Devices to coordinate the end-to-end execution of Prenuvo’s AI-enabled medical-device programs.
You will work across AI Research, Engineering, Systems Engineering, Product, Quality, Regulatory, Clinical, and other teams to turn technically complex medical-device initiatives into clear, executable programs.
You will connect product development, model development, systems engineering, validation, quality, regulatory readiness, launch, change management, and post-market activities into one integrated plan.
By making this work more structured and scalable, you will help Prenuvo’s AI and device teams increase their capacity to develop and evolve our product portfolio.
This role does not provide visa sponsorship. 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).
Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people’s lives!

Requirements

• 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.

Responsibilities

• 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.
• Set up and maintain 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.

Benefits

• Free, whole-body scans to each team member
• Flexible vacation policy
• Prenuvo’s Commuter Benefits Plan to help cover your transit and parking costs
• 401(k) retirement savings plan
• Comprehensive benefits package including health, dental, vision, including Mental Health coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed