Senior Device Development Engineer

3 days ago

Dombivli, Maharashtra, India beBeeDeviceDevelopment Full time ₹ 18,00,000 - ₹ 24,00,000
Job Description

This is a key role within our team responsible for leading the development of Meter Dose Inhaler dosage forms. The candidate will work closely with device manufacturers to select the right devices and ensure design verification meets user requirements.

The primary focus will be on conducting device development, 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 will also be provided.

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

The ideal candidate will have basic knowledge in medical devices, CFD & other simulation tools. A degree in engineering with ~12 years experience in medical device characterization is mandatory.

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.
  • 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.

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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