Device Development Professional
1 day ago
Job Title: Senior Device Development Engineer
As a senior device development engineer, you will be responsible for leading the design and development of medical devices, specifically Meter Dose Inhaler dosage forms. Your primary role will be to coordinate with device manufacturers to select the right devices and ensure compliance with defined user requirements.
The candidate will be responsible for developing test methods and fixtures, conducting relevant testing, validation, and in-silico clinical simulations to ensure patient safety, efficacy, and clinical outcomes. Additionally, they will be responsible for commercial product support for MDI portfolio.
The successful candidate will have a degree in engineering, preferably mechanical, and around 12 years of experience in medical device development or drug delivery devices in the pharmaceutical industry. They should have knowledge in medical devices, combination product development, and authoring Design History files.
Key Responsibilities:
- Lead device workstream for Metered Dose Inhaler Dosage form, from device selection, development, troubleshooting to regulatory submissions and commercial support.
- Support development of injectable drug-device combination products.
- Custom design/design troubleshooting of delivery devices.
- Build in-vitro setups, test various design iterations, analysis drug delivery performance.
- Laboratory experiment to validate simulation results.
- Mechanical Force testing expertise, Ability to design fixtures and test methods.
- Familiarity with aerosol testing methodologies.
- Drug deposition modelling and predictions, Familiarity with CFD, FEA tools.
- CFD interpretation from modelling data.
- Build models in MATLAB and interpret the results.
- Design history and clinical simulation documentation.
- Build protocols for patient specific device or robustness and compile information as per latest regulatory guidance and thinking.
- Build Design History File (DHF) per Design Controls, Support Documentation for combination products.
- Reference product characterization.
- Preparation of specifications, trade dress, different stage gate document.
- Threshold Analyses Device design history file/Design Controls for combination products.
- Capable to design the user requirements for combination products.
- Work with device manufacturer & Formulation team for completion of successful design verification, in compliance with various ISO/FDA requirements.
- Conduct Design validation (HF/Threshold Analysis).
- Work with formulation or different stake holder to complete device documentation such as functional specifications, quality attributes.
- Derive and user risk mitigation for combination product.
Required Skills and Qualifications:
- Engineering degree BE/BTech(Mechanical preferable)
- Relevant experience: Experience at reputed of around 12 years in medical device development or drug delivery devices in pharmaceutical industry
- Knowledge in medical devices/combination product development
- Knowledge in authoring Design History file
- Test Method development & validation
- Knowledge on Primary container closures system and regulatory expectations
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