Team Member/Manager - Medical Device
- Speed It Innovations
- 12 to 16 Yrs
- Maharashtra
- 4 months ago
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Job Description
- Role Overview: You will lead the device development for Metered Dose Inhaler (MDI) dosage form, coordinating with device manufacturers, designing verification tests, developing test methods, conducting relevant testing and validations, and providing commercial support for MDI portfolio. Additionally, you will be responsible for new product development of Injectable delivery devices, including technology selection, design fine-tuning, and development. Key Responsibilities: - Lead the device workstream for MDI dosage form, including device selection, development, troubleshooting, regulatory submissions, and commercial support. - Support the development of injectable drug-device combination products through custom design, troubleshooting, in-vitro setups, testing various design iterations, and analyzing drug delivery performance. - Conduct lab experiments to validate simulation results, perform mechanical force testing, design fixtures and test methods, and ensure familiarity with aerosol testing methodologies. - Utilize drug deposition modeling, CFD, FEA tools, and MATLAB to build models, interpret results, and document design history and clinical simulations. - Develop protocols for patient-specific devices, compile information per regulatory guidance, and prepare documentation for combination products. - Prepare specifications, trade dress, and different stage gate documents, maintain device design history files, and collaborate with stakeholders for successful design verification. - Conduct design validation, work on device documentation, and derive user risk mitigation for combination products. Qualifications Required: - Engineering degree in BE/BTech (Mechanical preferred) - Approximately 12 years of experience in medical device development or drug delivery devices in the pharmaceutical industry - Knowledge in medical devices, combination product development, authoring Design History File, test method development and validation, primary container closures system, and regulatory expectations,
Employement Category:
Employement Type: Full timeIndustry: Medical / HealthcareRole Category: Not SpecifiedFunctional Area: Not SpecifiedRole/Responsibilies: Team Member/Manager - Medical DeviceContact Details:
Company: CiplaLocation(s): Maharashtra+ View Contact
Keyskills: Medical devices CFD Simulation tools MATLAB Risk mitigation
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Speed It Innovations
Speed Innovation is a leading technology solutions provider that specializes in delivering innovative and agile digital transformation strategies. Our mission is to empower our clients to thrive in the digital age by leveraging the power of cutting-edge technologies. Vision: Making the world wiser...
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