Dein persönlicher KI-Karriere-Agent
Senior Systems Engineer(m/w/x)
System design and requirement allocation for engineered components in healthcare and advanced manufacturing. 4+ years systems engineering experience, embedded systems knowledge essential. Work on high-precision sub-systems for critical industry applications.
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
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
Berufserfahrung
- 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – fließend
- Englisch – verhandlungssicher
Tools & Technologien
- Polarion
- Doors
- SAP
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
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Senior Systems Engineer(m/w/x)
System design and requirement allocation for engineered components in healthcare and advanced manufacturing. 4+ years systems engineering experience, embedded systems knowledge essential. Work on high-precision sub-systems for critical industry applications.
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
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
Berufserfahrung
- 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – fließend
- Englisch – verhandlungssicher
Tools & Technologien
- Polarion
- Doors
- SAP
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
W.O.M. World of Medicine GmbH
Branche
Healthcare
Beschreibung
The company creates engineered components and sub-systems for healthcare and advanced manufacturing, enhancing productivity and precision.
Noch nicht perfekt?
- W.O.M. World of Medicine GmbH
Senior Systems Engineer Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Systems Engineer Disposables(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - Helsing
Systems Engineer - Land(m/w/x)
Vollzeitnur vor OrtManagementMünchen, Berlin - Novanta
Project Manager Medical Devices - MDR(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin