Senior Expert Engineer, Medical Devices & Autoinjectors

Novartis; Basel; Vor Ort; CHF 94.000 - 174.000; Vollzeit

Benefits dieser Stelle

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

Parental leave

Zusammenfassung

Novartis Basel-based Device Technology Solution Center seeks a Senior Expert Engineering to lead development of innovative drug-device combinations. The role focuses on autoinjectors, on-body injectors and other delivery methods, with close collaboration across PM, QA, regulatory and manufacturing.

You will drive design controls, DHF documentation, verification activities and strategic problem solving to ensure regulatory readiness and scalable manufacturing.

Qualifikationen

• Excellent verbal communication and English writing skills.
• 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 DHF documentation.

Aufgaben

• Provide technical leadership in cross-functional device development subteams for autoinjector and other drug-device products.
• Define design input requirements and specifications; author and review DHF documentation.
• Lead design verification and characterization activities to demonstrate compliance with requirements.
• Provide technical input to regulatory submissions and respond to health authority questions.
• Perform technical investigations and implement robust corrective actions.
• Ensure development activities comply with regulations and internal procedures.
• Collaborate with external partners, suppliers, CMOs and internal manufacturing to ensure successful development and industrialization.
• Ensure documentation supports clinical studies, registration and commercial manufacturing.
• Provide scientific guidance and promote engineering best practices.

Ausbildung

Mechanical Engineering or Biomedical Engineering

Tools

DHF Documentation

Jobbeschreibung

Novartis Basel-based Device Technology Solution Center seeks a Senior Expert Engineering to lead development of innovative drug-device combinations. The role focuses on autoinjectors, on-body injectors and other delivery methods, with close collaboration across PM, QA, regulatory and manufacturing.

You will drive design controls, DHF documentation, verification activities and strategic problem solving to ensure regulatory readiness and scalable manufacturing.