Systems Engineer Medical Devices & Disposables (m/f/d) - Entwicklung, Projektmanagement, IT

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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.

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