Senior Medical Device Development Specialist

13 hours ago

Aurangabad, Maharashtra, India beBeeDeviceDevelopment Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Description

Lead Device Workstream for Metered Dose Inhaler Dosage Form

The candidate will be responsible for co-ordinating with device manufacturers for selecting the right device and conducting design verification to comply with defined user requirements. The primary role is to take the lead in conducting device development for Meter Dose Inhaler dosage form.

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

Key responsibilities include test method/fixtures development, relevant testing, validation, In-silico clinical simulations that relate to patient safety, efficacy, and clinical outcomes. Commercial product support for MDI portfolio is also required.

Required Skills and Qualifications

Essential Qualifications:

  • Engineering degree (BE/BTech) in Mechanical or a related field
  • Relevant experience of around 12 years in medical device development or drug delivery devices in the pharmaceutical industry
  • Basic knowledge in medical devices, CFD & other simulation tools

Desirable Qualifications:

  • Knowledge in authoring Design History File
  • Test Method development & validation
  • Knowledge on Primary container closures system and regulatory expectations
Benefits

The ideal candidate will have a strong background in medical device characterization and a proven track record of successful device development. The candidate should be able to work independently and as part of a team, with excellent communication and project management skills.

Others

The candidate should have a strong understanding of device design history files/Design Controls for combination products. Additionally, they should be capable of designing user requirements for combination products and working with device manufacturers and formulation teams for completion of successful design verification, in compliance with various ISO/FDA requirements.

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