Job Summary

　　The Device Program Manager is responsible for owning the day-to-day activities of Program Management of Drug Delivery Device projects. The DPM will be interacting with external vendors to define deliverables including budget and schedule and all deliverables are met. DPM will interact with internal cross-functional teams to ensure all quality, regulatory and finance related documentation is satisfied. DPM will prepare management reports of each project to provide timely progress updates.

　　Essential Functions

　　Technical owner of work streams within the development of drug delivery systems from concept design to commercial prototypes as required by the project plan

　　Complete the risk management activities to meet project timescales, device performance and quality requirements

　　Ensure that all project inputs and outputs are thoroughly documented, providing a robust and detailed design history file

　　Prepare Device related Regulatory document for filing, responses to agency quires like IR, DRL, CR etc.

　　Coordinate with RA, Quality, Marketing, and other departments to create DHF documents including Risk management documents.

　　Coordinate with all stakeholders of the project to arrange and conduct periodic design reviews.

　　Skilled in the use of CAD tools, ideally SolidWorks

　　Experience of US and EU regulatory requirements for drug delivery systems

　　Experience with plastic design, manufacturing, and assembly