Drug Delivery Device Program Manager

Job Description

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

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

Qualifications

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 - AdvancedContract Manufacturing of Medical Devices - AdvancedValidation & Verification of injection mold tools & assembly machines - AdvancedRisk assessment and management - AdvancedISO standards, 21 CFR, EU MDR - Advanced

Specialized Knowledge

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

About Us

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.