Senior Medical Device Development Specialist

4 days ago

Meerut, Uttar Pradesh, India beBeeMedicalDeviceDevelopment Full time ₹ 18,45,000 - ₹ 22,47,000

Job Summary

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The successful candidate will lead and conduct device development for Meter Dose Inhaler dosage form.

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This includes coordinating with device manufacturers to select the right device, conducting design verification to comply with defined user requirements, and responsible for conduiting testing, validation, in-silico clinical simulations that relate to patient safety, efficacy, and clinical outcomes. Additionally, the candidate will be responsible for new product development for Injectable delivery devices.

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In this role, you will have the opportunity to work on a wide range of projects, from device selection and development to troubleshooting and regulatory submissions.

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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.">
  • 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.">
  • Laboratory 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, 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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Requirements

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  • ">
  • Engineering degree BE/BTech(Mechanical preferable)">
  • 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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