Project Manager – AI Medical Devices

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in project planning, scheduling, and tracking progress for various AI device initiatives.

• Work collaboratively with AI/ML engineers, systems engineers, regulatory affairs, product teams, and clinical operations to ensure deliverables are aligned across teams.

• Keep project documentation updated in Jira and other platforms, monitor milestones, and confirm that all design control and regulatory deliverables are current.

• Aid in preparing for regulatory submissions (such as 510(k), IDE, Health Canada) and organize/execute design control design reviews, including documenting clear summaries and follow-up actions.

• Provide consistent updates on project status, risks, and dependencies to leadership.

• Spot process inefficiencies and suggest ideas for enhancing collaboration, documentation flow, and delivery effectiveness.

⛳️ Requirements

• At least 2 years of experience managing projects in a healthcare setting.

• Knowledge of medical device lifecycle management, particularly in Software as a Medical Device (SaMD) development and verification.

• Exceptional organizational and time management abilities, with a keen eye for detail.

• Capability to handle multiple priorities and deadlines in a dynamic, cross-functional environment.

• Strong written and verbal communication skills to connect technical, regulatory, and business teams.

• Proficiency in project tracking tools (such as JIRA).

• Bachelor’s degree in Biomedical Engineering, Project Management, or a relevant technical or business field.

🏝️ Benefits

• An opportunity to positively influence people's lives and their health.

• Growth opportunities are central to our employee journey; we’re achieving great things with talented individuals - success can be shaped in various ways.

• Building strong relationships is fundamental to our operations - our team meets weekly to connect, share, and socialize.