(Senior) Design V&V Engineer 80%

Position Summary

This role will be located at the Bulach, Switzerland location which is responsible for the development, production and marketing of balloon catheters and drug-coated stent systems.  

The Design Verification & Validation department supports R&D, Production, and Regulatory Affairs in (Product development-) Projects and manages the verification and validation of design, components, and test methods. The support includes knowledge transfer, active collaboration and reviews.

Principal Responsibilities

• 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


• 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


• 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 Teleflex


• 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

Education / Experience Requirements

• Completed studies in a technical or scientific field with professional experience


• Several years of relevant professional experience, ideally in the field of DVV for electronic implants or electrical engineering


• 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, FDA/QSR, ISO 13485, ISO 14971, IEC 62366, cGxP, IEC 60601)


• Confident application of design verification/validation testing methodology/tools


• Experience in defining, organizing and leading domain related work packages


• Experience in interface functions and in working with external service providers


• Very good written and spoken German and English skills


• Team oriented, accurate and self-dependent personality with an analytical working style