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:

• 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. TuV, 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.

ADDITIONAL RESPONSIBILITIES:

• 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, ABILITITES:

• 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.

EDUCATION AND 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.

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 REQUIREMNTS:

• 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.

INTERFACE:

• 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.