Overview
In this role, you lead cross-functional device development for autoinjectors and drug-device combinations, guiding design inputs, verification, and DHF documentation. You’ll collaborate with regulatory, manufacturing, and external partners to deliver safe, effective delivery systems. Your work supports clinical studies, registrations, and commercial manufacturing, shaping cutting-edge delivery devices within a mission-driven team. You drive robust technical solutions and share engineering best practices, contributing to Novartis’s commitment to innovative medical devices.
Leistungen / Benefits
- insurance plans
- retirement plans
- wellbeing resources
- global recognition programs
- flexible and hybrid working options
- minimum 14 weeks paid parental leave
Verantwortungsbereiche
- 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/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, implement corrective actions to prevent recurrence
- 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 engineering best practices
Zentrale Anforderungen
- Degree in Mechanical Engineering, Biomedical Engineering, or a related discipline
- typically 10+ years in medical device and/or combination product development
- Excellent verbal communication and technical writing in English
- Demonstrated ability to influence cross-functional teams in a matrix environment
- Experience in design verification
- Knowledge of 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)
- strong communication skills
- leadership and influence in matrix environments
- problem solving and root cause analysis
- Design Controls and DHF management
- Design verification and characterization
- Regulatory submission support for device design and performance
Senior Expert Engineering in Basel Arbeitgeber: Novartis
Novartis in Schaftenau, Österreich, ist ein hervorragender Arbeitgeber, der eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf Mitarbeiterentwicklung und kontinuierlichem Lernen fördert das Unternehmen eine Kultur der Zusammenarbeit und Innovation. Die Möglichkeit, an globalen Projekten zu arbeiten und einen bedeutenden Einfluss auf die Gesundheitsversorgung zu haben, macht Novartis zu einem attraktiven Arbeitsplatz für Fachkräfte im Bereich Regulatory Affairs.
