Senior Medical Device Engineer

Are you ready to take the lead in device development for Meter Dose Inhaler dosage form? As a senior engineer, you will play a crucial role in co-ordinating with device manufacturers, conducting design verification, and ensuring compliance with user requirements. Your primary responsibilities will include developing test methods and fixtures, conducting relevant testing and validation, and performing in-silico clinical simulations that relate to patient safety, efficacy, and clinical outcomes.

In addition to your technical expertise, you will also be responsible for commercial product support for MDI portfolio. This includes new product development for Injectable delivery devices, including technology and device platform selection, design fine-tuning, and development. You should have a solid understanding of medical devices, CFD, and other simulation tools.

To be successful in this role, you will need a degree in engineering, preferably mechanical, and around 12 years of experience in medical device characterization. You will also need to be proficient in designing and troubleshooting delivery devices, building in-vitro setups, and analyzing drug delivery performance. Additionally, you should be familiar with aerosol testing methodologies, drug deposition modeling, and CFD interpretation.

This is an excellent opportunity to work on high-profile projects and contribute to the development of innovative medical devices. If you are a motivated and experienced engineer looking to take your career to the next level, we encourage you to apply.

We offer a competitive compensation package and a dynamic work environment that fosters growth and development. Our team is passionate about creating cutting-edge medical solutions that improve patients' lives. Join us and be part of our mission to revolutionize healthcare.

Key Responsibilities:

• Lead device workstream for Metered Dose Inhaler Dosage form, from device selection, development, troubleshooting to regulatory submissions and commercial support.
• Support development of injectable drug-device combination products.
• Custom design/design troubleshooting of delivery devices.
• Build in-vitro setups, test various design iterations, analyze drug delivery performance.
• Laboratory experiment to validate simulation results.
• Mechanical Force testing expertise, ability to design fixtures and test methods.
• Familiarity with aerosol testing methodologies.
• Drug deposition modeling and predictions, Famility with CFD, FEA tools.
• CFD interpretation from modelling data.
• Build models in MATLAB and interpret the results.
• Design history and clinical simulation documentation.
• Build protocols for patient specific device or robustness and compile information as per latest regulatory guidance and thinking.
• Build Design History File (DHF) per Design Controls, Support Documentation for combination products.
• Reference product characterization.
• Preparation of specifications, trade dress, different stage gate document.
• Threshold Analyses.
• Device design history file/Design Controls for combination products.
• Capable to design the user requirements for combination products.
• Work with device manufacturer & Formulation team for completion of successful design verification, in compliance with various ISO/FDA requirements.
• Conduct Design validation (HF/Threshold Analysis).
• Work with formulation or different stake holder to complete device documentation such as functional specifications, quality attributes.
• Derive and user risk mitigation for combination product.
• Educational qualifications: Engineering degree BE/BTech(Mechanical preferable)
• Relevant experience: Experience at reputed of around 12 years in medical device development or drug delivery devices in pharmaceutical industry
• Knowledge in medical devices/combo product dev.
• Authoring DHF knowledge
• Test Method development&validation
• Primary container closures system and regulatory expectations knowledge