Systems Engineer Medical Devices & Disposables (m/f/d)

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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.

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

General Tasks

• Strict compliance with the quality, occupational safety, and environmental regulations.
• Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist.

Required Experience, Education, Skills, Training and Competencies

• 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

Travel Requirements

• Willingness to travel to all locations and business contacts.

Physical Requirements

• Quality-conscious, trustworthy, and reliable
• Willingness to travel to all locations and business contacts.
• Able to work in a team.
• Very good communication skills.
• Structured, systematic and solution-oriented way of working.

Novanta ist stolz darauf, ein Unternehmen zu sein, das sich für Chancengleichheit bei der Beschäftigung und entsprechende Maßnahmen einsetzt. Wir berücksichtigen alle qualifizierten Bewerber ohne Rücksicht auf Hautfarbe, Religion, Geschlecht (einschließlich Schwangerschaft), sexuelle Orientierung, Geschlechtsidentität oder -ausdruck, nationale Herkunft, Behinderung oder andere Kategorien, die gesetzlich oder durch Novanta-Richtlinien geschützt sind.

Bitte kontaktieren Sie uns, wenn Sie für irgendeinen Teil des Beschäftigungsprozesses eine behindertengerechte Lösung benötigen.