Systems Engineer Disposables

Vor 3 Tagen

Berlin, Berlin, Deutschland Novanta Europe GmbH Vollzeit

Please check out the Novanta career site for detailed Job Description:

This position is part of Novanta's Advanced Surgery business unit group. Novanta offers highly reliable, precise and safe solutions that enhance system performance and improve patient outcomes. Insufflators, pumps and disposable tube sets, along with medical visualization and operating room integration technologies are the preferred solution for minimally invasive surgery applications.

We are looking for an Systems Engineer for our Disposables Team

Summary

This job 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 position is on medical accessories, e.g. tube sets for insufflators and pumps.

Tasks

Primary 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

Required Experience, Education, Skills, Training and Competencies

  • Training/Education:

  • Dipl.-Ing./Master of Medical Technology / Mechanical Engineering / Materials Engineering / Biology or equivalent

  • Technical Requirements Profile:

  • 3+ years of relevant work experience required. Preferably in the development of medical device disposable products.

  • 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 (CEFR-B2)*

  • Knowledge of SAP desirable

Travel Requirements

  • Willingness to travel to all locations and business contacts %)

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