- Région Zurich
- Type de contrat Permanent full time
- Secteur d'activité Industry / Production / Technical
For our client manufacturer of medical technology products and provider of services for electrotherapy of the heart and vessels, located in Bülach, we are looking for an individual as
(Senior) Design Verification & Validation Engineer
(unlimited contract, full-time). The earliest start date is as soon as possible or within the notice period.
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
- 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
Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application.
- Agence GLOBAL RECRUITMENT - +41 44 266 50 25
- Publié le 15. August 2022
- Consultant Jie Zhu