W.O.M. World of Medicine GmbH
Senior Systems Engineer(m/w/x)
Full-timeOn-siteSenior
Berlin
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W.W.O.M. World of Medicine GmbH
Senior Systems Engineer Medical Devices(m/w/x)
Berlin
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- SAP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of W.O.M. World of Medicine GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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W.W.O.M. World of Medicine GmbH
Senior Systems Engineer Medical Devices(m/w/x)
Berlin
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- SAP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of W.O.M. World of Medicine GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
W.O.M. World of Medicine GmbH
Industry
Healthcare
Description
The company creates engineered components and sub-systems for healthcare and advanced manufacturing, enhancing productivity and precision.
Not a perfect match?
- W.O.M. World of Medicine GmbH
Senior Systems Engineer(m/w/x)
Full-timeOn-siteSeniorBerlin - W.O.M. World of Medicine GmbH
Systems Engineer Disposables(m/w/x)
Full-timeOn-siteExperiencedBerlin - W.O.M. World of Medicine GmbH
Mechnical Design Engineer(m/w/x)
Full-timeOn-siteExperiencedBerlin - Novanta
Project Manager Medical Devices - MDR(m/w/x)
Full-timeOn-siteSeniorBerlin - W.O.M. World of Medicine GmbH
Mechanical Design Engineer(m/w/x)
Full-timeOn-siteExperiencedBerlin