Expert Engineering – Medical Device Development

Senior Design Engineer

Location: Basel, Switzerland #onsite

Role Purpose: 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.

Your Responsibilities:

Your responsibilities include, but are not limited to:

• Work on platform development and participate to project activities in cross-functional teams for easy-to-use, safe and robust products
• Participate to the complete development process of medical devices (ideation, brainstorming, prototyping, piloting and transfer to manufacturing)
• Create and review IP
• Create, manage and maintain CAD, 3D and drawings
• Create, manage and maintain 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 suggest 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
• Write key design history file documents: design input requirements, component specifications and design verification documents. Ensure device design development is delivered to a high quality

Role Requirements:

• Degree in mechanical engineering or equivalent
• Preferably 3 years of experience in medical device development
• Proficient spoken communication and excellent technical writing skills in English
• 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 in key regulations and standards (e.g. ISO23098, ISO 11608, ISO 10993, MDR, Design Controls)
• Design History File documentation
• Ability to interact with cross functional team in matrix organization
• Minimum 80% on site work – 4 days/week

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired