Device Development Specialist

1 week ago


Jamnagar, Gujarat, India beBeeMedical Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Title:

Device Development Specialist

">Job Description:

As a Device Development Specialist, you will lead the development of medical devices for Meter Dose Inhaler dosage form. This includes coordinating with manufacturers to select the right device and ensuring design verification meets user requirements.

The candidate will be responsible for developing test methods and fixtures, conducting relevant testing, validation, in-silico clinical simulations, and commercial product support for MDI portfolio.

You will also be responsible for new product development for Injectable delivery devices, including technology and device platform selection, design fine-tuning, and development.

Key skills required include basic knowledge of medical devices, CFD, and other simulation tools. A degree in engineering with around 12 years of experience in medical device characterization is mandatory.

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 and design troubleshooting of delivery devices.
  • Build in-vitro setups, test various design iterations, and 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 modeling 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 devices 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.
  • 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/combo product dev.
  • Knowledge in authoring Design History file.
  • Test Method development & validation.
  • Knowledge on Primary container closures system and regulatory expectations.


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