W.O.M. World of Medicine GmbH
Senior Systems Engineer Medical Devices(m/w/x)
Vollzeit
Senior
Keine Angabe
Berlin
W.
W.O.M. World of Medicine GmbH2 Monate
Senior Systems Engineer(m/w/x)
Vollzeit
Senior
Keine Angabe
Berlin
Nejo KI-Zusammenfassung
In this role, you will be at the forefront of product development, defining system designs, managing technical implementations, and ensuring compliance with industry standards. Your day-to-day responsibilities will involve collaborating with various stakeholders and supporting the transition of products from design to production.
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Anforderungen
- •Dipl.-Ing./Master in Electrical Engineering, Medical Engineering, Mechanical Engineering, Materials Engineering, Biology, or equivalent
- •4+ years of systems engineering experience
- •Very good knowledge of system development and/or software design
- •Very good knowledge of embedded systems, software, mechanics, and hardware
- •Expertise in defining requirements or requirements management systems
- •Experience in verification procedures
- •Experience in Design to Cost
- •Experience in the transfer of sterile tubing sets to the medical device industry
- •Experience in transferring medical devices to production
- •Knowledge of verification procedures
- •Knowledge of relevant norms, standards, and approval process (FDA; CE)
- •Fluent German
- •Good knowledge of English (at least B2)
- •Experience in use of requirement management tools (like Polarion, Doors)
- •SAP knowledge desirable
- •Quality-conscious, trustworthy, and reliable
- •Willingness to travel to all locations and business contacts
- •Team player
- •Very good communication skills
- •Structured, systematic, and solution-oriented way of working
Master-Abschluss
Berufserfahrung
4 Jahre
Deine Aufgaben
- •Define and document system design based on specified architecture
- •Analyze external and internal stakeholder requirements
- •Pre-select and allocate customer requirements to existing platform solutions
- •Coordinate with stakeholders as necessary
- •Define features for integration and create feature requests if needed
- •Implement new product features as reusable components of the platform
- •Create product-specific system specifications
- •Coordinate technical solutions across departments
- •Manage technical project components with the project manager
- •Support associated work packages with content-related guidance
- •Create and maintain technical documentation with the project manager
- •Manage product-specific risk in collaboration with the risk manager
- •Develop and implement product-specific verification plans
- •Oversee technical management of device constructions (Alpha, Beta, Vali)
- •Review and approve assembly instructions
- •Transfer products to production
- •Conduct standard tests of the device
- •Support production processes up to pilot series (NPI)
- •Provide technical support for production (PE)
- •Integrate domain-specific development results
- •Control material and parts list creation and management
- •Serve as the technical contact for customers, suppliers, and partners
- •Organize department-specific training
- •Assess the impact of changes in standards on the field
- •Collaborate intensively within the development department and company-wide
- •Participate actively in developing and applying company standards
- •Initiate and engage in synchronization processes and process improvements
- •Contribute to the innovation process
- •Ensure compliance with quality, safety, and environmental regulations
Tools & Technologien
PolarionDoorsSAP
Sprachen
Deutsch – fließend
Englisch – verhandlungssicher
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