Senior Medical Devices Development Lead

2 days ago

Hyderabad, Telangana, India beBeeDevelopment Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Device Development Specialist

As a key member of our Device Development team, you will be responsible for leading the development of Meter Dose Inhaler dosage form devices.

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
  • 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.

Requirements:

  • 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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