W.O.M. World of Medicine GmbH
Senior Systems Engineer(m/w/x)
Vollzeit
Senior
Keine Angabe
Berlin
W.
W.O.M. World of Medicine GmbH5 Tage
Senior Systems Engineer Medical Devices(m/w/x)
Vollzeit
Senior
Keine Angabe
Berlin
Nejo KI-Zusammenfassung
In this role, you will be at the forefront of developing medical devices, focusing on system design, feature implementation, and cross-department coordination. Your day-to-day responsibilities will involve collaborating with stakeholders, managing technical documentation, and ensuring compliance with industry standards.
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Anforderungen
- •Dipl.-Ing./Master in Electrical Engineering, Medical Engineering, Mechanical Engineering, Materials Engineering, Biology, or equivalent
- •5+ years of relevant work experience
- •Proven track record in development of medical devices (Class II)
- •Very good knowledge of system development and/or software design
- •Very good knowledge of embedded systems, software, mechanics, and hardware
- •Very good knowledge of mechanics, sterility, and biocompatibility
- •Very good experience in design to cost
- •Very good knowledge of manufacturing processes of sterile tubing sets
- •Expertise in defining requirements or requirements management systems
- •Experience in verification procedures
- •Experience in Design to Cost
- •Experience in transfer of sterile tubing sets to medical device industry
- •Experience in transferring medical devices to production
- •Knowledge of verification procedures
- •Knowledge of relevant norms, standards, and approval process (FDA; CE)
- •Good knowledge of English (GER-B2)
- •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
5 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 needed
- •Define 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 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 and hose set constructions
- •Facilitate design transfer of products to production
- •Review and approve assembly instructions
- •Conduct standard tests for the device and hose set
- •Support production processes up to pilot series
- •Provide technical support for production
- •Control creation and management of material and parts lists
- •Serve as technical contact for customers, suppliers, and internal departments
- •Organize department-specific training sessions
- •Assess applicants and participate in interviews
- •Supervise students
- •Evaluate the impact of changes in standards
- •Mentor team members
- •Collaborate intensively within the development department
- •Participate in the development of company standards
- •Initiate and engage in synchronization processes and process improvements
- •Contribute to the innovation process
- •Ensure compliance with quality, occupational safety, and environmental regulations
Tools & Technologien
SAP
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
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