Genomadix

Project Manager

• Lead medical device projects from R&D development through design transfer and manufacturing transfer
• Plan and execute manufacturing transfers with Operations, Quality, Supply Chain, and Regulatory
• Partner with R&D to manage development timelines, milestones, and phase-gate reviews
• Manage company-wide projects across Quality, Regulatory, Commercial, Customer Success, and Finance
• Build and maintain project plans, schedules, budgets, risk registers, and status reports
• Coordinate with external partners and suppliers, including Asia-based projects requiring early-morning meetings
• Identify risks and dependencies early and drive mitigation and escalation
• Ensure project work complies with applicable regulations and standards, including ISO 13485, FDA 21 CFR Part 820, Health Canada, and IVDR
• Communicate progress, issues, and decisions to team members and leadership