Beschreibung

As a Systems Engineer for the Disposables Team, you will focus on the technical implementation of medical accessories, ensuring compliance with design guidelines while collaborating with various stakeholders to meet customer requirements and manage product risks.

Anforderungen

• •Diploma or Master's in Medical Technology, Mechanical Engineering, Materials Engineering, Biology, or equivalent
• •3+ years of relevant work experience
• •Good knowledge in mechanics, sterility, biocompatibility
• •Experience in Design to Cost
• •Good knowledge of manufacturing processes of sterile tubing sets
• •Experience in defining requirements or requirement management systems
• •Knowledge of verification procedures
• •Experience in transferring products to production
• •Knowledge of relevant standards
• •Good knowledge of English (CEFR-B2)
• •Knowledge of SAP desirable
• •Willingness to travel to all locations and business contacts (10-15%)
• •Quality-conscious, trustworthy, and reliable
• •Willingness to travel to all locations and business contacts
• •Ability to work in a team
• •Very good communication skills
• •Structured, systematic and solution-oriented way of working

Aufgaben

• •Define and document system design based on architecture and platform development
• •Analyze external and internal stakeholder requirements
• •Pre-select and assign customer requirements to existing platform solutions
• •Coordinate with stakeholders as needed
• •Determine features for integration and create feature requests if necessary
• •Implement new product features as reusable components of the platform
• •Create product-specific system specifications
• •Coordinate technical solutions across departments
• •Manage technical project components and support associated work packages
• •Prepare and maintain technical documentation with the project manager
• •Oversee product-specific risk management with the risk manager
• •Develop and implement product-specific verification plans
• •Manage technical aspects of equipment and hose set constructions
• •Transfer product designs to production
• •Review and approve assembly instructions
• •Conduct standard tests for devices and tube sets
• •Support manufacturing processes up to pilot series
• •Provide technical support for production
• •Control material and BOM creation and management
• •Serve as the technical contact for customers during project acquisition
• •Ensure compliance with quality, occupational safety, and environmental regulations
• •Implement instructions from quality/environmental management and occupational safety specialists

Tools & Technologien