Senior Expert Engineering

Provide technical leadership in cross-functional device development subteams for autoinjector and other drug-device combination product development projects. Define design input requirements and specifications, and author, review, and approve Design History File (DHF) documentation. Lead design verification and characterization activities to demonstrate compliance with applicable requirements, standards, and intended use. Provide technical input to regulatory submission dossiers and support responses to health authority questions related to device design, performance, and verification activities. Perform technical investigations and root cause analyses, identify corrective actions, and implement robust technical solutions to prevent recurrence of product and process issues. Ensure development activities comply with applicable regulations, standards, and internal procedures. Collaborate with external partners, suppliers, contract manufacturers, and internal manufacturing organizations to ensure successful device development and industrialization. Ensure documentation and materials are delivered to support clinical studies, registration, and commercial manufacturing. Provide scientific and technical guidance to team members, facilitate knowledge sharing, and contribute to the development of engineering best practices.

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 Expert Engineering to lead the development of innovative drug-device combination products. We from the Device Technology Solution Center drives the technical development of autoinjectors as well as novel drug delivery principles, e.g. on-body injectors, inhalers or radioligand therapy. We closely collaborate with project management, human factors engineers, packaging experts, analytical testing, quality assurance, production, external partners, regulatory experts and many more. The objective is to develop and/or integrate innovative drug delivery systems with drug formulation and author state-of-the-art technical documentation for health authorities and production.

• Degree in Mechanical Engineering, Biomedical Engineering, or a related discipline

• Significant experience (typically 10+ years) in medical device and/or combination product development

• Excellent verbal communication and technical writing skills in English are required

• Demonstrated ability to influence cross-functional teams and lead technical initiatives in a matrix environment.

• Experience in design verification

• Good knowledge of applicable medical device regulations and industry standards

• Experience working with suppliers and CMOs

• Experience with Design Controls and Design History File (DHF) documentation

• Minimum 80% on site work (4 days/week)