
Medical Device Innovator
2 days ago
We are seeking a highly skilled Device Development Specialist to lead our device workstream for Metered Dose Inhaler (MDI) dosage form. This role will involve coordinating with device manufacturers, ensuring design verification meets user requirements, and overseeing test method/fixtures development.
- Developing test methods and fixtures for device testing
- Conducting relevant testing, validation, and clinical simulations for patient safety, efficacy, and outcomes
- Supporting commercial product development for MDI portfolio
In this position, you will have the opportunity to leverage your expertise in medical devices, computational fluid dynamics (CFD), and simulation tools to drive innovation and deliver high-quality solutions. A degree in engineering with at least 12 years of experience in medical device characterization is mandatory.
Key Responsibilities:- Lead device workstream for MDI dosage form, covering device selection, development, troubleshooting, 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, analyze drug delivery performance
- Lab experiments 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 results
- Design history and clinical simulation documentation
- Build protocols for patient-specific devices or robustness and compile information as per latest regulatory guidance
- 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 of designing 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 stakeholders to complete device documentation such as functional specifications, quality attributes
- Derive and user risk mitigation for combination product
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