Senior Medical Device Developer

22 hours ago

Solapur, Maharashtra, India beBeeDeviceDeveloper Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Key Responsibilities:

  • Lead the development of Meter Dose Inhaler dosage form from device selection to regulatory submissions and commercial support.
  • Support development of injectable drug-device combination products, including custom design and troubleshooting of delivery devices.

Requirements:

  1. Bachelor's degree in engineering (Mechanical preferable)
  2. At least 12 years of experience in medical device development or drug delivery devices in the pharmaceutical industry
  3. Knowledge in medical devices, combination product development, authoring Design History files, test method development and validation, primary container closures systems, and regulatory expectations

About the Role:

This is a challenging opportunity for an experienced medical device professional to take on a lead role in the development of innovative inhalation products. You will be responsible for leading cross-functional teams and collaborating with device manufacturers and formulation teams to deliver successful design verification and compliance with ISO/FDA requirements.

You will have a strong understanding of medical devices, combination product development, and regulatory expectations, as well as excellent communication and project management skills. If you are a motivated and results-driven individual who enjoys working in a dynamic environment, this could be the ideal role for you.

Device Development:

The candidate will be responsible for developing and implementing device development strategies, including technology/device platform selection, design fine-tuning, and development. They will also be responsible for building in-vitro setups, testing various design iterations, analyzing drug delivery performance, and conducting lab experiments to validate simulation results.

Lead Device Workstream:

The candidate will lead the device workstream for Metered Dose Inhaler Dosage Form, from device selection to regulatory submissions and commercial support. This will involve coordinating with device manufacturers, formulation teams, and other stakeholders to ensure timely and successful delivery of projects.

Drug-Device Combination Products:

The candidate will be responsible for supporting the development of injectable drug-device combination products, including custom design and troubleshooting of delivery devices. They will also be responsible for building protocols for patient-specific devices or robustness and compiling information as per latest regulatory guidance and thinking.

Skills and Qualifications:

The ideal candidate will have a strong background in medical devices, combination product development, and regulatory expectations. They will also possess excellent communication and project management skills, as well as the ability to work effectively in a dynamic environment.

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