Senior Expert Engineering – Medical Device Systems (Onsite)

Novartis; Lavamünd; Vor Ort; EUR 99.000 - 184.000; Vollzeit

Zusammenfassung

Novartis is seeking a Senior Expert Engineering to lead the development of autoinjectors and other drug-device combinations at its Device Technology Solution Center. This role focuses on technical leadership, design controls, and DHF documentation to ensure regulatory compliance and robust product development.

The successful candidate will collaborate across functions, partner with suppliers and CMOs, and drive verification activities, while ensuring on-site work 4 days per week and a strong

Qualifikationen

• Degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Significant experience (10+ years) in medical device and/or combination product development.
• Excellent verbal communication and technical writing skills in English.
• 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)

Aufgaben

• 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.

Kenntnisse

Cross-functional leadership

English communication

Technical writing

Regulatory knowledge

Design Controls

Ausbildung

Bachelors in Mechanical or Biomedical Engineering

Jobbeschreibung

Novartis is seeking a Senior Expert Engineering to lead the development of autoinjectors and other drug-device combinations at its Device Technology Solution Center. This role focuses on technical leadership, design controls, and DHF documentation to ensure regulatory compliance and robust product development.

The successful candidate will collaborate across functions, partner with suppliers and CMOs, and drive verification activities, while ensuring on-site work 4 days per week and a strong