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Prenuvo

Technical Program Manager – AI Medical Devices

RemoteUnited States, Canada only
Published
Role
Fullstack
Experience
Senior
Employment
Full-time
$170k–$200k/yr
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Open to US, CA only. Set where you work from to check your eligibility.

No BS summary

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.

Core skills

JiraMachine LearningAI/ML

Required skills

Software as a Medical DeviceDesign ControlsRisk ManagementVerification and ValidationChange ControlPost-Market ProcessesFDAHealth 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 preventative healthcare for everyone, including our team - Prenuvo provides free, whole-body scans to each team member
  • 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 now offer the Prenuvo’s Commuter Benefits Plan to help cover your transit and parking costs. Whether you ride, drive, or park, we’ve got you covered—making your commute easier and more affordable!
  • Prenuvo offers a 401(k) retirement savings plan to eligible employees, allowing team members to make pre-tax contributions toward their retirement. While Prenuvo facilitates access to the plan, the company does not currently offer matching contributions.
  • We offer a comprehensive benefits package including health, dental, vision, including Mental Health coverage, to support you and your family.

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
$170k–$200k/yr