
Senior Medical Device Developer
3 days ago
Job Summary:
As a lead device developer, you will be responsible for leading the development of Meter Dose Inhaler dosage form devices. This includes coordinating with manufacturers, conducting design verification to ensure user requirements are met, and developing test methods and fixtures.
You will also be responsible for commercial product support for the MDI portfolio and new product development for injectable delivery devices. This involves selecting technology/device platforms, fine-tuning designs, and developing products.
The ideal candidate will have a strong background in medical devices, CFD & simulation tools, and engineering degree with at least 12 years of experience in medical device characterization.
Responsibilities:
- Lead device workstream for Metered Dose Inhaler Dosage form
- Develop injectable drug-device combination products
- Custom design/design troubleshooting of delivery devices
- Build in-vitro setups, test design iterations, and analyze drug delivery performance
- Design fixtures and test methods
- Familiarity with aerosol testing methodologies
- Drug deposition modeling and predictions, CFD interpretation from modeling data
- Build models in MATLAB and interpret results
- Compile Design History File (DHF) per Design Controls
- Document combination products
- Reference product characterization, specifications, trade dress, and stage gate documents
- Threshold Analyses
Requirements:
• Strong background in medical devices and CFD & simulation tools
• Engineering degree with at least 12 years of experience in medical device characterization
• Experience with device development and commercial product support
• Strong communication and project management skills
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