
Medical Device Development Specialist
2 days ago
As a key member of our team, you will play a crucial role in the development of innovative medical devices, specifically Meter Dose Inhaler dosage form. Your expertise in device development and leadership skills will be invaluable in guiding our workstream from device selection to regulatory submissions and commercial support.
Responsibilities include leading device workstreams for MDI dosage form, supporting the development of injectable drug-device combination products, custom designing delivery devices, building in-vitro setups, testing design iterations, analyzing drug delivery performance, and validating simulation results through lab experiments.
Additionally, you will possess mechanical force testing expertise, familiarity with aerosol testing methodologies, drug deposition modeling, CFD interpretation, and MATLAB programming skills. You will also be responsible for designing history files, clinical simulations, documentation, and threshold analyses.
Our ideal candidate will have an engineering degree, preferably in Mechanical Engineering, with at least 12 years of experience in medical device development or drug delivery devices in the pharmaceutical industry. They will also have knowledge in medical devices, combination product development, authoring Design History files, test method development, validation, and primary container closures systems.
Required Skills & Qualifications:- Education: BE/BTech (Mechanical preferable)
- Experience: Relevant experience: At least 12 years in medical device development or drug delivery devices in the pharmaceutical industry
- Skills: Knowledge in medical devices / combination product development, authoring Design History file, test method development & validation, primary container closures system and regulatory expectations
We offer a dynamic work environment that fosters collaboration, innovation, and growth. Join us in shaping the future of medical device development.
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