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.
About the role
- Technical Program Manager coordinating AI-enabled medical-device development at Prenuvo, a preventive whole-body imaging company. Integrating engineering, validation, quality, regulatory, launch, and post-market programs.
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 submissions
- Plan and execute design-control design reviews, including capturing 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
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 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
- 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
- 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
- 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
- Excellent program-planning, dependency-management, and risk-management skills
- Exceptional communication and ability to create clarity across specialized technical disciplines
- Comfort operating in a fast-moving environment where scaling processes are still being built
- Successful candidates will undergo a background check in compliance with applicable federal, provincial, and state rules
Benefits
- Positive impact on people's lives and health
- Free whole-body scans for each team member
- Growth opportunities and flexible career paths
- Weekly team gatherings to connect, share, and socialize
- Flexible vacation policy
- Commuter Benefits Plan covering transit and parking costs
- 401(k) retirement savings plan with pre-tax contributions; no company matching contributions
- Comprehensive health, dental, vision, and Mental Health coverage
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