Team Member / Manager - Medical Device Development

JD

Role is to take the lead and conduct device development for Meter Dose Inhaler dosage form. Primary role is to co-ordinate with device manufacturers for selecting the right device and responsible for conduiting design verification to comply the defined user requirements. The candidate will be responsible for test method / fixtures development, relevant testing, validation, In-silico clinical simulations that relate to patient safety, efficacy and clinical outcomes. Commercial product support for MDI portfolio.

Additionally, candidate will be responsible for new product development for Injectable delivery devices – including technology / device platform selection, design fine tuning and development .

Should have basic knowledge in medical devices, CFD & other simulation tools. Degree in engineering with ~12 years experience in medical device characterization mandatory.

Device Development

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

Lab 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, Famility 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.

Educational 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