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Prenuvo

Technical Program Manager, AI Medical Devices

RemoteCanada, United States only
Published
Role
Fullstack
Experience
Senior
Employment
Full-time
CAD 150k–CAD 175k/yr
Check eligibility

Open to CA, US only. Set where you work from to check your eligibility.

No BS summary

Coordinate the end-to-end execution of Prenuvo’s AI-enabled medical-device programs, working across AI Research, Engineering, Systems Engineering, Product, Quality, Regulatory, Clinical, and other teams to turn technically complex medical-device initiatives into clear, executable programs.

Core skills

Jira/Machine Learning/AI/ML

Required skills

Software as a Medical Device/Design Controls/Risk Management/Verification and Validation/Change Control/Post-Market ProcessesFDA/Health Canada

Optional skills

ISO 13485ISO 14971IEC 62304AI/ML-enabled medical devicesSaMDClinical validationClinical-performance evaluation

What you'll do

  • Program Coordination: 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 clear summaries and follow-ups.
  • Reporting and Communication: Facilitate reporting and communicate project status, risks, and dependencies to the program team and stakeholders.
  • Continuous Improvement: Identify process gaps and contribute ideas to improve collaboration, documentation flow and delivery efficiency.

What they require

  • 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.

Benefits

  • An avenue to make a positive impact on people's lives and their health
  • We believe in preventive healthcare for everyone. This role includes whole-body scans as part of our employee benefits
  • Growth opportunities are at the heart of our people journey, we’re doing big things with bright minds - there is no single path to success, it can be shaped along the way
  • 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. While Prenuvo provides access to these plans, the company does not currently offer matching contributions.

Prenuvo provides fast, safe, non-invasive whole body MRI scans and uses optimized hardware, software, and AI across domestic and global clinics for proactive healthcare.

Healthcare

Details

Visa sponsorshipNo
CAD 150k–CAD 175k/yr