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Senior Systems Engineer Medical Devices(m/w/x)
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
Noch nicht perfekt?
- W.O.M. World of Medicine GmbHVollzeitnur vor OrtSeniorBerlin
- W.O.M. World of Medicine GmbH
Systems Engineer Disposables(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
Mechnical Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Mechanical Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin
Senior Systems Engineer Medical Devices(m/w/x)
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
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 - Novanta
Project Manager Medical Devices - MDR(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - W.O.M. World of Medicine GmbH
Mechnical Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Mechanical Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin