KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.
For more than 70 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.
The system engineer is 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.
The system engineer is 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.
- 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, SKILLS, ABILITIES:
- Communicates well with required project contacts.
- Experience with the majority of the product development life cycle at Karl Storz or similar industry.
- Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001)
A System Engineer will have knowledge, skills, and abilities in some of these areas.
- Ability to perform system tradeoff studies.
- Experience withvideo systems
- Knowledgeable of image prossing 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
EDUCATION AND EXPERIENCE:
- BS / Masters / PHD degree in Electrical Engineering, Physics, Electrical Computer Engineering, Computer Science plus 5+ years industry experience followed with 5+ years in the role of Systems Engineer.
PHYSICAL & MENTAL REQUIREMENTS:
- 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
TRAINING REQUIREMENT: .
- Injury and Illness Prevention Program
- Quality System training
- Job Specific - In house requirement
LEVEL OF SUPERVISION REQUIRED:
·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