Senior Medical Device Development Specialist

4 days ago

Varanasi, Uttar Pradesh, India beBeeDeviceDevelopment Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Description">

Overview:

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We are seeking a highly skilled and experienced Device Development Lead to join our team. The successful candidate will be responsible for leading the development of Meter Dose Inhaler dosage forms, including device selection, design verification, testing, validation, and commercial support.

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Key Responsibilities:

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  • ">
  • Co-ordinate with device manufacturers to select the right device;">
  • Conduct design verification to comply with defined user requirements;">
  • Develop test methods and fixtures;">
  • Conduct relevant testing and validation;">
  • Perform In-silico clinical simulations related to patient safety, efficacy, and clinical outcomes;">
  • Support commercial product development for MDI portfolio;">
  • Lead new product development for Injectable delivery devices, including technology and device platform selection, design fine-tuning, and development;">
  • Collaborate with formulation and other stakeholders to complete device documentation, such as functional specifications and quality attributes;">
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Required Skills and Qualifications:

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Education:

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Bachelor's or Master's degree in Engineering (Mechanical preferred);

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Experience:

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At least 12 years of experience in medical device characterization or drug delivery devices in the pharmaceutical industry;

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Knowledge and Skills:

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Basic knowledge in medical devices and CFD;

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Ability to design fixtures and test methods;

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Familiarity with aerosol testing methodologies;

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Drug deposition modeling and predictions;

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CFD interpretation from modelling data;

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Ability to build models in MATLAB and interpret results;

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Design history and clinical simulation documentation;

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Preparation of specifications, trade dress, and different stage gate documents;

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Benefits:

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This role offers a unique opportunity to work on innovative projects, collaborate with cross-functional teams, and develop your skills and expertise in device development.

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Other Requirements:

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The ideal candidate will have excellent communication and project management skills, as well as the ability to work effectively in a fast-paced environment.

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