Stronger together

At KARL STORZ, we believe in not just creating jobs 
but building careers. As a family-run company, 
we understand the value of long-term relationships and 
actively work on promoting them.
When YOU grow, we grow.

Get to know us and join our team as

Systems Engineer IV

Location: 

Goleta, CA, US, 93117

Job ID:  2927

 

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


2927


Nearest Major Market: Santa Barbara
Nearest Secondary Market: Santa Maria