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    Verification & Validation Engineer (m/w/d) - Rostock, Deutschland - BIOTRONIK

    BIOTRONIK
    BIOTRONIK Rostock, Deutschland

    vor 1 Woche

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    Ganztags
    Beschreibung

    (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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