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Genomadix

Project Manager

Genomadix

. Lead medical device projects from R&D development through design transfer and manufacturing transfer .

Posted 9/25/2026full-timeOttawa • CanadaMid-LevelSenior💰 CA$90,000 - CA$120,000 per yearWebsite

Tech Stack

Tools & technologies
PMP

About the role

Key responsibilities & impact
  • 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

Requirements

What you’ll need
  • 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, including 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
  • Preferred: In vitro diagnostics (IVD) experience; pharmacogenetics or molecular diagnostics experience
  • Preferred: PMP or equivalent project management certification
  • Preferred: Experience working with contract manufacturers
  • Preferred: Familiarity with FDA 510(k)/De Novo, Health Canada medical device licensing, or IVDR
  • Preferred: Experience working in a small or growing company

Benefits

Comp & perks
  • Full-time, permanent employment
  • Hybrid work in Ottawa, ON or remote in Canada
  • Occasional, minimal travel