Medical Device Development Specialist

19 hours ago


Kolkata, West Bengal, India beBeeDevelopment Full time ₹ 15,00,000 - ₹ 20,25,000
Job Overview

The role involves spearheading device development for Meter Dose Inhaler dosage form. This includes coordinating with manufacturers to select the right device and ensuring design verification complies with defined user requirements.

Key responsibilities include:

  • Developing test methods and fixtures
  • Conducting relevant testing, validation, and in-silico clinical simulations for patient safety, efficacy, and clinical outcomes
  • Providing commercial product support for MDI portfolio

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

Required skills and experience:

  • Basic knowledge in medical devices, CFD, and other simulation tools
  • Degree in engineering with approximately 12 years of experience in medical device characterization
  • Knowledge of aerosol testing methodologies, drug deposition modeling, and CFD/FEA tools
Responsibilities

Lead device workstream for Metered Dose Inhaler Dosage form, from device selection 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, and analyze drug delivery performance.

Lab experiments to validate simulation results.

Design history and clinical simulation documentation.

Build protocols for patient-specific device or robustness and compile information as per latest regulatory guidance.

Device design history file/design controls for combination products.

Capable to design user requirements for combination products.

Work with device manufacturer & Formulation team for completion of successful design verification, in compliance with various ISO/FDA requirements.



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