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About the role
- Project Manager coordinating AI device programs for Prenuvo's AI-enabled Software as a Medical Device initiatives. Collaborating with cross-functional teams and maintaining project documentation.
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.
- 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.
- Provide regular updates on project progress, risks and dependencies to leadership.
- Identify process gaps and contribute ideas to improve collaboration, documentation flow and delivery efficiency.
Requirements
- Minimum of 2 years of experience coordinating projects in a healthcare environment.
- Familiarity with medical device lifecycle management, especially Software as a Medical Device (SaMD) development and verification.
- Excellent organizational and time management skills with strong attention to detail.
- Ability to manage multiple priorities and deadlines in a fast-paced, cross-functional environment.
- Strong written and verbal communication skills to bridge technical, regulatory and business teams.
- Proficiency with project tracking tools (such as JIRA)
- Bachelor’s degree in Biomedical Engineering, Project Management, or a related technical or business discipline.
Benefits
- An avenue to make a positive impact on people's lives and their health
- 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
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