Systems Engineer IV
Goleta, CA, US, 93117
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:
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System Design
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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
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Develop and maintain ownership of system architecture documentation.
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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.
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Perform the necessary tradeoffs (reliability, cost, schedule, manufacturability, etc.) of various design approaches and select an optimal approach.
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Develop system design specifications, including subsystems and system variations.
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Make sure that all components are working seamlessly together as one system.
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Decompose the system (product) requirements into hardware, software, optical, and mechanical design specifications.
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Participate in the system risk analysis.
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Assist in defining Essential Performance
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Define network and insulation diagram.
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Participate in creation of technical system documentation.
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Track and review the detailed hardware, software, optical, and mechanical design to ensure it meets the objective and requirements identified in the system documents.
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Develop and execute plan for integration and test of product components comprising the system.
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Review system verification plan and system verification procedures
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Work with Compliance Engineer to coordinate external system testing with notified body, e.g. TüV, UL, etc.
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Ensure traceability between system requirements and verification testing. Responsible for overall system performance
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Manage system configurations (configuration management)
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Collaborate with project management in Agile Development activities.
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Analyses and Modeling
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Perform system analysis and modeling to support tradeoff studies as required.
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Develop means (tests) of analyzing system components to objectively quantify performance.
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Determine methods of communicating the analytical results with the rest of the Engineering staff.
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Determine, where appropriate, empirical methods, to validate analytical models. If necessary, update the model assumptions and/or empirical methods to correlate the results.
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Document the results of the analyses in technical reports.
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Research and Development
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Research and develop new technology for use in future and existing OR1 products.
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Communicate with purchasing and vendors for new processes and capabilities required for new designs.
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Sustaining Support
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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.
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Documentation of system changes.
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General Engineering
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Provide support and technical direction for the generation and maintenance of the system Design Assurance Checks.
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Regular attendance is an essential job function.
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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:
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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.
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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.
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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.
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Performs other related duties as assigned by supervisor.
KNOWLEDGE, SKILLS, ABILITITES:
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Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001)
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Communicates well with required project contacts, seeks to communicate, and form relationships with non-required contacts.
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Experience with all of the product development life cycle at Karl Storz or similar industry.
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Ability to perform system tradeoff studies.
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Experience with video systems
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Knowledgeable of image processing techniques
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Solid understanding of software design methodology and deliverables
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Understanding of networks (protocols, topologies, etc.)
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Thorough understanding of microprocessor-controlled systems
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Broad understanding of analog and digital hardware design.
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General understanding of optical design, optical materials, and coatings
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General understanding of mechanical issues including adhesives, sealing techniques and sterilization requirements
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Expert level skills in documenting and communicating system design deliverables and drawings.
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Highly desirable to have medical systems product design experience.
EDUCATION AND EXPERIENCE:
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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:
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Visual acuity sufficient for testing
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Ability to sit for extended periods (during meetings and computer work)
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Ability to lift video equipment.
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Ability to connect electrical devices.
TRAINING REQUIREMNTS:
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Injury and Illness Prevention Program
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Quality System training
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Job Specific - In house requirement
LEVEL OF SUPERVISION REQUIRED:
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The department manager develops general goals for the employee at the yearly review cycles, which are derived from the overall company goals.
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Tasks are derived from these general goals by the employee and reviewed and accepted by the department manager.
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Detail peer review of work accomplished is required and scheduled as required.
INTERFACE:
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Product management to understand the end user requirements.
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Project Engineers and Project Managers for system design and tradeoff studies
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Manufacturing Engineers for manufacturability issues
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Interact with KARL STORZ departments globally.
Nearest Major Market: Santa Barbara
Nearest Secondary Market: Santa Maria