Drug Delivery Device Program Manager
📋 Role Overview & Responsibilities
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 SolidWorksExperience of US and EU regulatory requirements for drug delivery systemsExperience 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.
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This position is located in Piscataway, NJ with potential relocation and sponsorship assistance depending on candidate qualifications.
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