Project Manager (AI Medical Devices)

TL;DR

Project Manager (AI Medical Devices): Supporting the planning and execution of AI-enabled Software as a Medical Device (SaMD) initiatives with an accent on project coordination, regulatory compliance, and cross-functional alignment. Focus on managing design control deliverables for regulatory submissions (510(k), IDE) and synchronizing deliverables between AI/ML engineers and clinical operations.

Location: Remote (Must be legally authorized to work in the USA or Canada)

Salary: $38.6–$40 per hour

Company

Medtech company specializing in proactive healthcare through AI-powered whole-body MRI scans.

What you will do

• Coordinate project planning, scheduling, and progress tracking for multiple AI device programs.
• Align deliverables across AI/ML engineers, systems engineers, regulatory affairs, and clinical operations.
• Maintain project documentation and track milestones within Jira.
• Ensure readiness for regulatory submissions (e.g., 510(k), IDE, Health Canada) and execute design control reviews.
• Communicate project progress, risks, and dependencies to leadership.
• Identify and resolve process gaps to improve delivery efficiency and documentation flow.

Requirements

• Minimum 2 years of project coordination experience in a healthcare environment.
• Familiarity with medical device lifecycle management and SaMD development/verification.
• Legal authorization to work in the USA or Canada without visa sponsorship.
• Proficiency with JIRA and strong organizational skills.
• Bachelor’s degree in Biomedical Engineering, Project Management, or a related technical/business field.

Nice to have

• PMP certification or related coursework.
• Knowledge of design control processes.
• Experience with AI/ML workflows or medical imaging systems (MRI, DICOM).

Culture & Benefits

• Opportunity to make a positive impact on proactive healthcare.
• Culture based on pioneering, ownership, and a patient-first mindset.
• Weekly team connections for socializing and knowledge sharing.
• Growth opportunities tailored to individual career paths.