Senior Device Development Engineer
22 hours ago
The role involves leading the development of Meter Dose Inhaler devices, collaborating with manufacturers to select suitable components and ensuring design verification meets user requirements.
Candidates will be responsible for developing test methods, testing, validation, and in-silico clinical simulations related to patient safety, efficacy, and clinical outcomes.
They will also develop commercial product support for MDI portfolios and contribute to new product development for injectable delivery devices.
Key Responsibilities:- Lead device workstream for Metered Dose Inhaler Dosage form from selection to regulatory submissions.
- Develop custom drug-device combination products and troubleshoot delivery devices.
- Establish in-vitro setups, test designs, analyze drug delivery performance, and validate simulation results through lab experiments.
- Design fixtures and test methods, possess mechanical force testing expertise.
- Apply aerosol testing methodologies, conduct drug deposition modeling and predictions, and interpret CFD data.
- Engineering degree (Mechanical preferable)
- 12 years of experience in medical device development or drug delivery devices in the pharmaceutical industry.
- Knowledge in medical devices, combination product development, and authoring Design History files.
- Test method development and validation, primary container closures system knowledge, and regulatory expectations.
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