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

Education

• Bachelors Degree (BA/BS) in Engineer/Mechanical Bio-medical - Required

Work Experience

• 5 years or more in Mid Manager/Program Manager/Med Device Industry - Required

Skills and Abilities

• Design and Development of Drug Delivery Systems - Advanced


• Contract Manufacturing of Medical Devices - Advanced


• Validation & Verification of injection mold tools & assembly machines - Advanced


• Risk assessment and management - Advanced


• ISO standards, 21 CFR, EU MDR - Advanced

Specialized Knowledge

• Specialized knowledge and management of drug delivery device or combination product devices.

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.