Medical Devices Systems Engineer

vor 2 Wochen

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

Role Summary

This position is responsible for the technical implementation of products based on defined architecture and master specifications in accordance with company-wide design control guidelines. The development focus of this role is on medical accessories, e.g., tube sets for insufflators and pumps.

Main 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)

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