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.


Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity