Senior Medical Device Development Engineer

2 days ago

Kollam, Kerala, India beBeeDeviceDevelopment Full time ₹ 1,81,20,000 - ₹ 2,31,64,000

Job Title: Device Development Lead

We are seeking a skilled and experienced professional to lead our device development efforts for Meter Dose Inhaler dosage form. The successful candidate will have a strong background in medical devices, engineering principles, and project management.

Job Description:

The Device Development Lead will be responsible for leading the development of innovative device solutions for Meter Dose Inhaler dosage form. This includes coordinating with manufacturers, designing verification, developing test methods/fixtures, conducting relevant testing, validation, in-silico clinical simulations, and commercial product support.

New product development for Injectable delivery devices involves technology/device platform selection, design fine tuning, and development. The successful candidate will have experience in drug-device combination products, custom design/design troubleshooting of delivery devices, building in-vitro setups, testing various design iterations, analyzing 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 modelling and predictions, CFD interpretation from modelling data, building models in MATLAB and interpreting results, design history and clinical simulation documentation, build protocols for patient-specific device or robustness, 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:
  • Bachelor's degree in Engineering (Mechanical preferable)
  • Relevant experience: Experience at reputed organizations 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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