MedTech Technical Project Lead — MDR & ISO 13485

albedis; Zürich; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

albedis is seeking an experienced Technical Project Manager for a MedTech client in the German-speaking part of Switzerland. You will lead technical development, verification, validation, and industrialization of medical devices, coordinating cross-functional teams through regulatory gates to market introduction.

Fluency in German and English is required. Strong expertise in design controls, risk management, and regulatory submissions is essential for successful project delivery.

Qualifikationen

• Degree in Mechanical Engineering, Biomedical Engineering or Medical Technology.
• Experience managing technical projects in the medical device industry.
• Knowledge of design controls, V&V, and manufacturing constraints.

Aufgaben

• Lead technical project scope, timelines, budgets, and resources from concept to production readiness.
• Coordinate cross-functional teams across R&D, QA, Regulatory, Clinical, and Manufacturing.
• Ensure compliance with ISO 13485 and MDR during all project phases.
• Drive risk assessments (DFMEA) and lifecycle management for device safety.
• Review and maintain Design History File and documentation for regulatory submissions.

Kenntnisse

Cross-functional leadership

Regulatory knowledge

Project management

DFMEA

3D CAD

Ausbildung

Mechanical Engineering

Biomedical Engineering

Medical Technology

Tools

3D CAD

Jobbeschreibung

albedis is seeking an experienced Technical Project Manager for a MedTech client in the German-speaking part of Switzerland. You will lead technical development, verification, validation, and industrialization of medical devices, coordinating cross-functional teams through regulatory gates to market introduction.

Fluency in German and English is required. Strong expertise in design controls, risk management, and regulatory submissions is essential for successful project delivery.