What are the responsibilities and job description for the Technical Program Lead - Medical Device position at Amneal?
Description:
The Medical Device Engineering Manager is responsible for owning the day-to-day Program Management activities of Drug Delivery Device projects. The incumbent will be interacting with external vendors to define deliverables including budget and schedule and all deliverables are met. Will interact with internal cross-functional teams to ensure all quality, regulatory and finance related documentation is satisfied. They 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
- Experience with plastic design, manufacturing, and assembly
- 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.
- Skilled in the use of CAD tools, ideally SolidWorks
- Coordinate with all stakeholders of the project to arrange and conduct periodic design reviews.
- Experience of US and EU regulatory requirements for drug delivery systems
Qualifications:
Education:
- Bachelors Degree (BA/BS) Engineer/Mechanical Bio-medical - Required
Experience:
- 5 years or more in Mid Manager/Program Manager/Med Device Industry
Skills:
- 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.
