- System Design
- Derive and maintain ownership of top-level system requirements by collaborating with stake holder representatives- Program Management, Manufacturing, Regulatory, Quality Assurance- to understand User Needs
- Develop and maintain ownership of system architecture documentation.
- Ensure that all authors (including the Systems Engineer) of separate design specifications have articulated the specifications in enough detail to design a system that meets all defined and approved product requirements.
- Perform the necessary tradeoffs (reliability, cost, schedule, manufacturability, etc.) of various design approaches and select an optimal approach.
- Develop system design specifications, including subsystems and system variations.
- Make sure that all components are working seamlessly together as one system.
- Decompose the system (product) requirements into hardware, software, optical, and mechanical design specifications.
- Participate in the system risk analysis.
- Assist in defining Essential Performance
- Define network and insulation diagram.
- Participate in creation of technical system documentation.
- Track and review the detailed hardware, software, optical, and mechanical design to ensure it meets the objective and requirements identified in the system documents.
- Develop and execute plan for integration and test of product components comprising the system.
- Review system verification plan and system verification procedures
- Work with Compliance Engineer to coordinate external system testing with notified body, e.g. TüV, UL, etc.
- Ensure traceability between system requirements and verification testing. Responsible for overall system performance
- Manage system configurations (configuration management)
- Collaborate with project management in Agile Development activities.
- Analyses and Modeling
- Perform system analysis and modeling to support tradeoff studies as required.
- Develop means (tests) of analyzing system components to objectively quantify performance.
- Determine methods of communicating the analytical results with the rest of the Engineering staff.
- Determine, where appropriate, empirical methods, to validate analytical models. If necessary, update the model assumptions and/or empirical methods to correlate the results.
- Document the results of the analyses in technical reports.
- Research and Development
- Research and develop new technology for use in future and existing OR1 products.
- Communicate with purchasing and vendors for new processes and capabilities required for new designs.
- Sustaining Support
- Provide sustaining support for existing product lines. This may include analysis of field issues and/or analysis of manufacturing issues. Recommend, where appropriate, design system changes.
- Documentation of system changes.
- General Engineering
- Provide support and technical direction for the generation and maintenance of the system Design Assurance Checks.
- Regular attendance is an essential job function.
- Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of products and services .
- Quality - all activities associated with this position must be performed with the highest level of quality standards recognizing that the products are used in the medical industry.
- Durability - all activities associated with this position must address the long-term durability of the device and where appropriate must consider the long-term durability.
- Efficacy - all activities associated with this position must consider the devices final application; ergonomics, interaction of the device with the physician, and device operation during usage are all components of efficacy.
- Performs other related duties as assigned by supervisor.
- Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001)
- Communicates well with required project contacts, seeks to communicate, and form relationships with non-required contacts.
- Experience with all of the product development life cycle at Karl Storz or similar industry.
- Ability to perform system tradeoff studies.
- Experience with video systems
- Knowledgeable of image processing techniques
- Solid understanding of software design methodology and deliverables
- Understanding of networks (protocols, topologies, etc.)
- Thorough understanding of microprocessor-controlled systems
- Broad understanding of analog and digital hardware design.
- General understanding of optical design, optical materials, and coatings
- General understanding of mechanical issues including adhesives, sealing techniques and sterilization requirements
- Expert level skills in documenting and communicating system design deliverables and drawings.
- Highly desirable to have medical systems product design experience.
- BS / Masters / PHD degree in Electrical Engineering, Physics, Electrical Computer Engineering, Computer Science plus 9+ years industry experience followed with 5+ years in the role of Systems Engineer.
- Visual acuity sufficient for testing
- Ability to sit for extended periods (during meetings and computer work)
- Ability to lift video equipment.
- Ability to connect electrical devices.
- Injury and Illness Prevention Program
- Quality System training
- Job Specific - In house requirement
- The department manager develops general goals for the employee at the yearly review cycles, which are derived from the overall company goals.
- Tasks are derived from these general goals by the employee and reviewed and accepted by the department manager.
- Detail peer review of work accomplished is required and scheduled as required.
- Product management to understand the end user requirements.
- Project Engineers and Project Managers for system design and tradeoff studies
- Manufacturing Engineers for manufacturability issues
- Interact with KARL STORZ departments globally.
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Systems Engineer IV - Goleta, United States - KARL STORZ Endoscopy - America
Description
Job Description
JOB SUMMARY:Responsible for product design at system level. He/she works closely together with product management, project management, development, and production in order to design a product that fulfills customer, manufacturing, service, market and regulatory requirements.
Responsible for system requirements and system architecture, reviews sub-system requirements and architectures, and leads system integration efforts, as well as verification reports through the development life cycle.
POSITION FUNCTIONS:
