Senior Drug-Delivery Device Engineer & Tech Lead

Roche; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche is seeking a senior mechanical engineer to lead the development of medical device and drug-delivery systems. You will drive robust engineering practices, collaborate with QA, Regulatory, and Clinical teams, and ensure products meet stringent quality and regulatory standards across the lifecycle.

The role requires a strong background in parenteral delivery systems, materials science, and hands-on experience with device design controls. Fluency in English is required; German is a plus.

Qualifikationen

• Bachelor's or Master's degree in engineering from an accredited institution.
• 10+ years in mechanical engineering and drug delivery device development in regulated environments.
• Hands-on expertise with pen injector and autoinjector development across product lifecycle.

Aufgaben

• Drive robust development of drug-delivery devices and combination products across lifecycle.
• Provide technical leadership and problem-solving to ensure design robustness and compliance.
• Lead investigations and document design controls, URS, design inputs/outputs, verification/validation plans.
• Collaborate with QA, Regulatory, Clinical, and Commercial teams to meet regulatory expectations.

Kenntnisse

Mechanical engineering

Drug delivery

Regulatory compliance

Cross-functional leadership

Design controls

Materials science

Parenteral delivery

QA/QC awareness

Ausbildung

BSc or MSc in engineering

Jobbeschreibung

Roche is seeking a senior mechanical engineer to lead the development of medical device and drug-delivery systems. You will drive robust engineering practices, collaborate with QA, Regulatory, and Clinical teams, and ensure products meet stringent quality and regulatory standards across the lifecycle.

The role requires a strong background in parenteral delivery systems, materials science, and hands-on experience with device design controls. Fluency in English is required; German is a plus.