Systems Engineer IV

2 weeks ago

Goleta, United States KARL STORZ Endoscopy - America Full time
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. 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 .


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.


Get in Contact

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