Lead disposable medical device development projects from concept through production and commercialization
Develop and maintain project schedules, budgets, resource plans, and Design & Development Plans
Coordinate project activities across engineering, manufacturing, quality, and other internal departments
Serve as the primary customer contact for project status updates, timelines, risks, and issue resolution
Manage project scope, deliverables, and timelines to ensure successful project execution
Support quotation and project planning activities in collaboration with Business Development
Coordinate personnel, equipment, and resources to meet project milestones
Collaborate with outside vendors for sourcing materials, components, and specialized processing
Monitor project progress and proactively communicate schedule changes or risks to stakeholders
Ensure projects are executed in compliance with FDA, ISO, and company quality system requirements
Identify opportunities for continuous improvement within project management processes
Maintain compliance with all applicable SOPs and quality system requirements included in the Training Matrix

Bachelor’s or master’s degree in engineering required
PMP certification or other project management certification preferred
Minimum 3 years of engineering experience in the medical device industry
Experience managing projects from concept through commercialization preferred
3+ years of project management or project engineering experience highly preferred
Experience working within FDA and ISO regulated environments preferred
Strong understanding of disposable medical device design and development
Experience with materials selection, prototyping, and product development processes
Excellent organizational, analytical, and problem-solving skills
Ability to manage multiple projects and priorities simultaneously
Proficiency in Microsoft Office and other project management tools/applications

R&D Project Manager – Medical Devices

Key skills