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.

· System Design

o 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

o Develop and maintain ownership of system architecture documentation

o 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

o Perform the necessary tradeoffs (reliability, cost, schedule, manufacturability, etc.) of various design approaches and select an optimal approach

o Develop system design specifications, including subsystems and system variations

o Make sure that all components are working seamlessly together as one system

o Decompose the system (product) requirements into hardware, software, optical, and mechanical design specifications

o Participate in the system risk analysis

o Assist in defining Essential Performance

o Define network and insulation diagram

o Participate in creation of technical system documentation

o Track and review the detailed hardware, software, optical, and mechanical design to ensure it meets the objective and requirements identified in the system documents.

o Develop and execute plan for integration and test of product components comprising the system

o Review system verification plan and system verification procedures

o Work with Compliance Engineer to coordinate external system testing with notified body, e.g. TüV, UL, etc.

o Ensure traceability between system requirements and verification testing. Responsible for overall system performance

o Manage system configurations (configuration management)

o Collaborate with project management in Agile Development activities

· Analyses and Modeling

o Perform system analysis and modeling to support tradeoff studies as required.

o Develop means (tests) of analyzing system components to objectively quantify performance.

o Determine methods of communicating the analytical results with the rest of the Engineering staff.

o Determine, where appropriate, empirical methods, to validate analytical models.If necessary, update the model assumptions and/or empirical methods to correlate the results.

o Document the results of the analyses in technical reports.

· Research and Development

o Research and develop new technology for use in future and existing OR1 products.

o Communicate with purchasing and vendors for new processes and capabilities required for new designs.

· Sustaining Support

o 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.

o Documentation of system changes.

· General Engineering

o 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 withvideo 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

#LI - LS1