06 Sep
|
Prenuvo
|
Toronto
At Prenuvo, we are on a mission to flip the paradigm from reactive “sick-care” to proactive health care. 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.
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! Support project planning, scheduling and progress tracking for multiple AI device programs. Cross-Functional Alignment: Collaborate closely with AI/ML engineers, systems engineers, regulatory affairs, product teams and clinical operations to keep deliverables synchronized across teams.
Documentation Management: 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.
Quality and Compliance: Support readiness for regulatory submissions (such as 510(k), IDE, Health Canada)
and plan/execute design control design reviews, including capturing explicit summaries and follow-ups. Facilitate reporting and communicate project status, risks, and dependencies to the program team and stakeholders.
Continuous Improvement: 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.
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.
Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. We’re always building foundations that allow us to achieve tomorrow more than we did today. An avenue to make a positive impact on people's lives and their health We believe in preventive healthcare for everyone.
Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize Recognizing time away to restore is vital to our wellbeing - we have a flexible vacation policy and we will encourage you to use it We offer a comprehensive benefits package including health, dental, vision, including Mental Health coverage, to support you and your family Prenuvo offers eligible Canadian employees access to both RRSP and TFSA retirement savings plans, with immediate, optional enrollment and the flexibility to invest and save for the future on your own terms. The base salary for this role ranges from $150,000-$175,000 in local currency, depending upon experience and geographic location We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
As part of the hiring process, successful candidates will undergo a background check in compliance to applicable federal, provincial, and state rules. #
📌 Technical Program Manager, AI Medical Devices (Toronto)
🏢 Prenuvo
📍 Toronto