Senior Expert Engineering - Medical Device Development

At Novartis, we are reimagining medicine to improve and extend people's lives. We discover and develop breakthrough treatments and find new ways to bring cures to as many people as possible. Without safe, easy-to-use, high-quality drug delivery devices our patients could not get their medicines. This is where you come in, the Device Technology Solution Center is looking for a Senior Design Engineer for the development of drug device combination products.

The aim is to develop a new auto-injector platform from early phase development to market launch.

About the Role

Your Responsibilities:

Your responsibilities include, but are not limited to:

• Work on platform device development and participate to project activities in cross-functional teams to deliver easy-to-use, safe and robust products
• Contribute to the complete development process of medical devices: ideation, brainstorming, prototyping, piloting, manufacturing and complaint handling
• Create and review IP
• Work with CAD, 3D, drawings, tolerance analysis
• Size and specify plastic and metallic components
• Work with third party suppliers, including prototyper, tool makers, CMOs
• Manage testing and characterization for acceptance, compliance, performance etc., and implement improvements
• Perform root cause analysis and develop robust solutions to prevent re-occurrence
• Ensure components are delivered and controlled to the required quality for clinical trials and commercial production
• Author key design history file documents: design input requirements, component specifications and design verification documents.

• Degree in mechanical engineering or equivalent
• Preferably 10 years of experience in medical device development
• Proficient oral communication and excellent technical writing skills in English is a must
• Experience in designing plastic and metal components; tolerance analysis; metrology; lab testing
• Experience in material qualification
• Good knowledge in design for manufacturing and assembly
• Good knowledge of key regulations and standards
• Track record in Design History File documentation
• Ability to interact with cross functional team in matrix organization
• Minimum 80% on site work - 4 days/week

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve., Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture