Medical Device Development Lead

21 hours ago

Thrissur, Kerala, India beBeeDevelopment Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Description

The ideal candidate will lead the development of Meter Dose Inhaler dosage form, collaborating with device manufacturers to select the appropriate devices and ensuring design verification aligns with user requirements. Primary responsibilities include coordinating test methods/fixtures development, relevant testing, validation, in-silico clinical simulations for patient safety, efficacy, and clinical outcomes. Additionally, this role involves commercial product support for MDI portfolio.

New product development for Injectable delivery devices, including technology/device platform selection, design fine-tuning, and development, is also a key responsibility. The candidate should have basic knowledge in medical devices, CFD & other simulation tools. A degree in engineering with approximately 12 years of 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.
  • 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.
Requirements

An 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

Benefits

This role offers an opportunity to contribute to the development of innovative medical devices and combination products.

A collaborative and dynamic work environment supports professional growth and development.

Excellent compensation and benefits package available.

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