Team Lead Developer

16 hours ago

Thiruvananthapuram, Kerala, India beBeeMedicalDevice Full time ₹ 25,50,000 - ₹ 34,20,000
Job Title: Team Member/ManagerJob Description:

The role involves taking the lead in conducting device development for Meter Dose Inhaler dosage form.

This includes coordinating with manufacturers to select the right device and ensuring design verification compliance with user requirements.

Key responsibilities include developing test methods, conducting relevant testing, validation, and In-silico clinical simulations to ensure patient safety, efficacy, and clinical outcomes for commercial products.

Additionally, the candidate will be responsible for new product development for Injectable delivery devices.

A basic knowledge of medical devices, CFD, and other simulation tools is required.

A degree in engineering with approximately 12 years of experience in medical device characterization is mandatory.

Responsibilities:
  • Lead device workstream for Metered Dose Inhaler Dosage form from device selection 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 modelling and predictions.
  • Familiarity 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 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.

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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