Project Manager - AI Medical Devices (12-Month Contract)
External
Prenuvo · RemotePrepare for this interview
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About the role
At Prenuvo , we are on a mission to flip the paradigm from reactive "sick-care" to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). 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 looking for a Project Manager - AI Medical Devices (Contractor) to support the planning and execution of Prenuvo's AI-enabled Software as a Medical Device (SaMD) initiatives This role does not provide visa sponsorship. 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). 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!
Responsibilities
- Project 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: 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: Provide regular updates on project progress, risks and dependencies to leadership.
- Continuous Improvement: Identify process gaps and contribute ideas to improve collaboration, documentation flow and delivery efficiency.
Requirements
- A strong sense of teamwork, accountability and follow-through: You value clarity, communication and collective success.
- 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.
- Certification or coursework in project management (such as PMP).
- Knowledge of design control processes.
- Exposure to AI/ML workflows or medical imaging systems (MRI, DICOM).
- Our Values
- First: we are Pioneers
- Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding.
- Second: we are Platform-Builders
- We're always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of what's ahead - in a mindset of ownership and duty to our mission.
- Above all: we are Patients
- We could all be the next person who walks through our very doors, seeking clarity or peace of mind. We are proud of our impact on our patients' lives, and we won't stop till everyone can benefit from our work.
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