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Systems Engineer for Sterile Tubing Sets

vor 1 Monat


Berlin, Berlin, Deutschland W.O.M. Vollzeit

Systems Engineer for Sterile Tubing Sets

We are seeking a highly skilled Systems Engineer to join our team at W.O.M. as a Systems Engineer for Sterile Tubing Sets. In this role, you will be responsible for the technical implementation of products based on defined architecture and master specifications in accordance with company-wide design control guidelines.

Key Responsibilities:

  • Definition and documentation of the system design on the basis of the given architecture and platform development, taking into account regulatory and normative provisions.
  • Analysis of external/internal stakeholder requirements.
  • Pre-selection and assignment of customer requirements to existing solutions of the platform, coordination with stakeholders if necessary.
  • Determination of the features to be integrated, creation of a feature request if necessary.
  • Responsibility for the technical implementation of new product features, preferably as a reusable component of the platform.
  • Creation of product-specific system specifications.
  • Coordination of technical solutions between the individual departments
  • Technical management of the technical project components and content support of the associated work packages (target definition, DoD) together with the project manager and the departments.
  • Preparation and maintenance of technical documentation together with the project manager.
  • Responsible for product-specific risk management in cooperation with the risk manager.
  • Responsible for the product-specific verification plans and their successful implementation.
  • Technical management of the equipment and hose set constructions (Alpha, Beta, Vali).
  • Transfer (design transfer) of the products to production.
  • Responsible for the review and approval of assembly instructions.
  • Responsible for the standard tests of the device and tube sets.
  • Support of manufacturing processes up to pilot series (NPI); Technical support of production (PE).
  • Control of material and BOM creation/management.
  • Preparation and maintenance of technical documentation together with the project manager.
  • Responsible for the technical approval of the products by the customer.
  • Technical contact person for customers (e.g. project acquisition

Requirements:

  • Training/Education: Dipl.-Ing./Master of Electrical Engineering/ Medical Technology/ Mechanical Engineering or Materials Engineering/ Biology or equivalent
  • Technical Requirements Profile: Several years of experience in the development of products in the role of Systems Engineer. Good knowledge in the fields of mechanics, sterility, biocompatibility. Experience in Design to Cost. Good knowledge of manufacturing processes of sterile tubing sets (gluing, welding, packaging, etc.). Experience in defining requirements or requirement management systems. Knowledge of verification procedures. Experience in transferring products to production. Knowledge of the relevant standards. Good knowledge of English & German (at least B2). Knowledge of SAP desirable