Senior Expert Engineer: Drug-Device Innovation Lead

Biopharma Careers; Basel; Vor Ort; CHF 94.000 - 174.000; Vollzeit

Benefits dieser Stelle

Hybrid working options

Parental leave

Insurance plans

Retirement plans

Zusammenfassung

Novartis’ Device Technology Solution Center seeks a Senior Expert Engineering to lead the development of innovative drug‑device combination products, including autoinjectors and on‑body injectors. You will collaborate with project management, human factors engineering, packaging, analytical testing, quality, production, and regulatory teams.

The role focuses on delivering DHF/Design Control documentation, guiding verification, ensuring regulatory compliance, working with suppliers and CMOs, and

Qualifikationen

• Degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Typically 10+ years in medical device or combination product development.
• Excellent verbal communication and English writing skills.
• Ability to influence cross-functional teams in a matrix environment.
• Experience with design verification and DHF documentation.
• Knowledge of medical device regulations and industry standards.
• Experience with suppliers and CMOs.
• 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; 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

Technical leadership

Cross-functional collaboration

DHF documentation

Design verification

Regulatory knowledge

Root cause analysis

Supplier/CMO experience

English communication

Ausbildung

Bachelor's degree in Mechanical or Biomedical Engineering

Jobbeschreibung

Novartis’ Device Technology Solution Center seeks a Senior Expert Engineering to lead the development of innovative drug‑device combination products, including autoinjectors and on‑body injectors. You will collaborate with project management, human factors engineering, packaging, analytical testing, quality, production, and regulatory teams.

The role focuses on delivering DHF/Design Control documentation, guiding verification, ensuring regulatory compliance, working with suppliers and CMOs, and