Medical Devices Technical Lead

1 day ago


Vadodara, Gujarat, India beBeeDeviceDeveloper Full time ₹ 25,00,000 - ₹ 30,00,000
Job Overview

The role involves leading device development for Meter Dose Inhaler dosage form, requiring coordination with device manufacturers, selection of the right device, and ensuring design verification complies with defined user requirements.

Test method/fixtures development, relevant testing, validation, in-silico clinical simulations are also key components. Commercial product support is necessary for the MDI portfolio.

New product development for Injectable delivery devices is expected to include technology/device platform selection, design fine-tuning, and development.

Key qualifications for this position include a degree in engineering, around 12 years of experience in medical device characterization, and basic knowledge in medical devices, CFD, and other simulation tools.

  • 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, analyze 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, 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 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 stakeholder to complete device documentation such as functional specifications, quality attributes.
  • Derive and user risk mitigation for combination product.


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