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Tech Stack
Tools & technologiesPMP
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
- IVD experience, pharmacogenetics or molecular diagnostics, PMP or equivalent certification, contract manufacturer experience, regulatory submission familiarity, and small/growing company experience are preferred qualifications
Benefits
Comp & perks- Full-Time, Permanent employment
- Occasional, minimal travel
- Remote work arrangement