W.O.M. World of Medicine GmbH
Senior Systems Engineer(m/w/x)
Vollzeitnur vor OrtSenior
Berlin
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W.W.O.M. World of Medicine GmbH
Senior Systems Engineer Medical Devices(m/w/x)
Berlin
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
System design and requirements allocation for Class II medical devices at a manufacturer of precision healthcare components. 5+ years experience in medical device development (Class II) and embedded systems knowledge required. Project-based system design, cross-functional team collaboration.
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
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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- SAP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens W.O.M. World of Medicine GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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W.W.O.M. World of Medicine GmbH
Senior Systems Engineer Medical Devices(m/w/x)
Berlin
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
System design and requirements allocation for Class II medical devices at a manufacturer of precision healthcare components. 5+ years experience in medical device development (Class II) and embedded systems knowledge required. Project-based system design, cross-functional team collaboration.
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
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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- SAP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens W.O.M. World of Medicine GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Systems Engineer Disposables(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Mechnical Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - Novanta
Project Manager Medical Devices - MDR(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Mechanical Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin