Senior Expert Engineering – Medical Device Development

Novartis seeks a Senior Design Engineer in Basel to lead the development of a new auto-injector platform from early stages through to market launch, ensuring safe, robust, and user-friendly drug-device combination products.

This position is based within the Device Technology Solution Center and focuses on the end-to-end creation of a novel auto-injector platform. The engineer will guide the project from initial concept and ideation through to commercial launch, ensuring the final device meets high standards for usability, safety, and reliability.

Responsibilities

• Collaborate within cross-functional teams to advance platform device development, ensuring the delivery of products that are safe, robust, and user-friendly.
• Oversee the full medical device lifecycle, including ideation, brainstorming, prototyping, piloting, manufacturing support, and complaint resolution.
• Generate and evaluate intellectual property documentation.
• Utilize CAD and 3D modeling tools to produce drawings and conduct tolerance analysis.
• Select and size plastic and metallic parts for the device.
• Coordinate with external partners such as prototypers, tool makers, and contract manufacturing organizations.
• Plan and execute testing and characterization activities to verify acceptance, compliance, and performance, then apply findings to drive improvements.
• Conduct root cause analysis to identify issues and implement durable solutions that prevent recurrence.
• Ensure all components meet quality standards for both clinical trials and commercial production.
• Draft and review essential Design History File records, including design inputs, component specifications, and verification documents.

Requirements

• Bachelor's or higher degree in mechanical engineering or a closely related field.
• Typically around 10 years of professional experience in medical device development.
• Strong oral communication abilities and excellent technical writing skills in English.
• Hands-on experience designing plastic and metal components, performing tolerance analysis, metrology, and laboratory testing.
• Background in material qualification processes.
• Solid understanding of design for manufacturing and assembly principles.
• Familiarity with relevant regulations and industry standards.
• Proven ability to maintain comprehensive Design History File documentation.
• Capacity to collaborate effectively within a matrix organization and across cross-functional teams.
• Willingness to work on-site at least four days per week (minimum 80%).

About the company

Novartis is dedicated to fostering an inclusive workplace environment with diverse teams that reflect the patients and communities the organization serves.

• Commitment to building an outstanding and inclusive work environment.
• Focus on maintaining diverse teams that represent the patients and communities served.