Introduction

Description de la mission

• Planning, execution/coordination and documentation of design verification & validation activities within development projects, re-certification projects and product maintenance
• Preparation of the DVV strategy and high-level design verification & validation plans and assessments including the review of the associated documentation within the scope of development projects and product maintenance
• Support of the technical departments in the context of authority queries and audits on the subject of design verification & validation and technical support/advice of the interfaces in connection with design verification & validation activities
• Ensure compliance with internal requirements (SOPs, WIs, etc.) and external requirements (laws, standards, etc.)
• Contribute to the development/optimization and maintenance of the Design Verification & Validation processes and documentation at Biotronik VI
• Development and deployment of competencies in the area of Design Control & Risk Management
• Participation in interdepartmental expert groups in the field of Design Verification & Validation

Profil attendu

• Completed studies or comparable training with ideally several years of professional experience
• Product knowledge in the field of medical devices, vascular intervention and combination products is an advantage
• Knowledge of international regulatory requirements in the area of test method validations (including MDR, MDD, QSR, ISO 13485, ISO 14971, IEC 62366, cGxP)
• Confident application of design verification/validation testing methodology/tools.
• Experience in defining, organizing and leading domain related work packages
• Very good knowledge English, written and spoken; German is an advantage

Application process: