Device Development Manager

2 weeks ago

Guntur, Andhra Pradesh, India beBeeDeviceDevelopment Full time ₹ 20,00,000 - ₹ 25,00,000

Device Development Lead

Job Summary:

Lead the development of Meter Dose Inhaler dosage form devices, coordinating with manufacturers and conducting design verification to meet user requirements. Develop test methods and fixtures, perform relevant testing, validation, and In-silico clinical simulations for patient safety and efficacy.

Key Responsibilities:

  • Conduct device selection and development, troubleshooting, and regulatory submissions
  • Develop injectable drug-device combination products, custom design/design troubleshooting of delivery devices
  • Build in-vitro setups, test design iterations, analyze drug delivery performance, and validate simulation results through lab experiments
  • Apply mechanical force testing expertise, design fixtures, and test methods; familiarity with aerosol testing methodologies
  • Model and predict drug deposition, interpret CFD data, and build models in MATLAB
  • Document design history and clinical simulation information, build protocols for patient-specific devices or robustness, and compile documentation as per latest regulatory guidance

Requirements:

Education and Qualifications:

  • Engineering degree (BE/BTech, Mechanical preferable)

Experience and Skills:

  • 12+ years' experience in medical device development or drug delivery devices in pharmaceutical industry
  • Knowledge in medical devices/combination product development, authoring Design History Files, test method development/validation
  • Understanding of primary container closures systems and regulatory expectations

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