Project Manager

Genomadix is seeking a Project Manager or Senior Project Manager to lead cross-functional initiatives across the organization. The role focuses on medical device R&D development programs, manufacturing transfers, project planning, risk management, regulatory compliance, and company-wide coordination.

Responsibilities:

• Lead medical device projects from R&D development through design transfer and manufacturing transfer
• Plan and execute manufacturing transfers in coordination 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 functions including 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 that require early-morning meetings
• Identify risks and dependencies early, and drive mitigation and escalation
• Ensure project work complies with applicable regulations and standards (e.g., ISO 13485, FDA 21 CFR Part 820, Health Canada, IVDR)
• Communicate progress, issues, and decisions clearly to team members and leadership

Requirements:

• Minimum 5 years of project management experience within a medical device PMO environment
• Demonstrated experience supporting manufacturing transfers and R&D product development
• Experience managing cross-functional projects across a variety of business functions
• Working knowledge of design controls, change control, and quality management systems
• Proficiency with project management tools and methodologies (e.g., MS Project, Smartsheet; Waterfall, Agile, or hybrid)
• Strong communication, organizational, and stakeholder management skills
• Bachelor's degree in Engineering, Life Sciences, Business, or a related field
• Available for regular early-morning meetings to support Asia-based projects
• Able to travel occasionally
• In vitro diagnostics (IVD) experience; pharmacogenetics or molecular diagnostics a strong asset
• PMP or equivalent project management certification
• Experience working with contract manufacturers
• Familiarity with FDA 510(k)/De Novo, Health Canada medical device licensing, or IVDR
• Experience working in a small or growing company