Associate Director, Device Tech Transfer
Core
Provide strategic program leadership and technical expertise for the scale-up, development, commercialization, and transfer of medical devices and combination products, specifically autoinjectors and prefilled syringes.
Role type
Associate Director, Device Tech Transfer
Builds
Medical devices and combination products for global commercialization
Domain
Medical Devices / Drug Delivery Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technology Transfer, Design Controls, Design Verification, Risk Management, Process Validation, Project Management, Regulatory Compliance, Manufacturing Methodologies, Materials Engineering, Product Development
Preferred skills
Mechanical Engineering, Chemical Engineering, Biomedical Engineering
Technologies
ISO 13485, ISO 14971
Responsibilities
Develop and execute strategic plans for technology transfer; Provide Voice of Manufacturing input to early development teams; Author regulatory filing sections; Support regulatory inspections and maintain proficiency in quality management systems; Secure stakeholder alignment for projects; Build strategic partnerships with manufacturing sites.
Seniority
Senior, hands-on IC with leadership responsibilities
