Senior Device Development Specialist

3 days ago

Kottayam, Kerala, India beBeeDeviceteamlead Full time ₹ 90,00,000 - ₹ 1,20,00,000
Job Title

A device development lead is required to manage and execute device development projects for Meter Dose Inhaler dosage form. The primary role is to coordinate with device manufacturers, select the right devices, and conduct design verification to comply with defined user requirements.

The candidate will be responsible for test method/fixtures development, relevant testing, validation, in-silico clinical simulations related to patient safety, efficacy, and clinical outcomes. They must also support commercial product development for the MDI portfolio.

Additionally, the candidate will be responsible for new product development for injectable delivery devices, including technology/device platform selection, design fine-tuning, and development.

About You
  • Basic knowledge of medical devices, CFD & other simulation tools.
  • Degree in engineering with ~12 years of experience in medical device characterization mandatory.
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, analyze 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 modeling and predictions, familiarity with CFD, FEA tools.
  • CFD interpretation from modeling data.
  • Build models in MATLAB and interpret results.
  • Design history and clinical simulation documentation.
  • Build protocols for patient-specific devices 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 analysis.
  • Device design history file/Design Controls for combination products.
  • Capable to design 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 stakeholder 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/combo 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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