Senior Device Development Specialist

2 days ago

Udaipur, Rajasthan, India beBeeDevelopment Full time ₹ 14,33,920 - ₹ 21,26,400

We are seeking an experienced Device Development Specialist to lead our efforts in developing innovative Meter Dose Inhaler dosage forms.

The ideal candidate will have a strong background in medical device development, with expertise in co-ordinating with device manufacturers and conducting design verification to ensure compliance with user requirements. They will also be responsible for test method development, testing, validation, in-silico clinical simulations related to patient safety, efficacy, and clinical outcomes, as well as commercial product support for MDI portfolio.

Additionally, the candidate will play a key role in new product development for Injectable delivery devices, including technology and device platform selection, design fine-tuning, and development.

The successful candidate will possess a degree in engineering, preferably mechanical, with around 12 years of experience in medical device characterization. They will also have basic knowledge in medical devices, CFD, and other simulation tools.

This is a fantastic opportunity for someone who is passionate about medical device development and wants to make a real difference in the field.

Main 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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