(Senior) Verification

vor 4 Wochen


Rostock, Deutschland BIOTRONIK Vollzeit

(Senior) Verification & Validation Engineer (m/w/d)

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

Design Verification & Validation supports R&D, Production, and Regulatory Affairs in the verification and validation of design, components, process, and test methods. This support includes knowledge transfer, active collaboration and reviews.

Your responsibilities

Planning, execution/coordination and documentation of verification & validation activities within development projects, re-certification projects and product maintenance Preparation of the V&V strategy and high-level 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 verification & validation and technical support/advice of the interfaces in connection with 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 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 Verification & Validation


Your profile

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 & process 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

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