Senior Medical Device Developer

16 hours ago

Gandhinagar, Gujarat, India beBeeDevelopment Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Device Development Expert

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The successful candidate will be responsible for taking the lead in device development, conducting thorough research and analysis to drive innovation. This includes coordinating with manufacturers to select the right devices and ensuring compliance with user requirements.

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In addition to this, the candidate will be responsible for developing test methods and fixtures, conducting relevant testing, validation, and clinical simulations to ensure patient safety and efficacy. They will also provide commercial product support for our Metered Dose Inhaler portfolio.

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We are seeking a highly skilled individual with a degree in engineering and at least 12 years of experience in medical device characterization. The ideal candidate will have knowledge in medical devices, CFD & other simulation tools.

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Key Responsibilities:

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  • ">
  • 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. ">
  • 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.">
  • 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 / 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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