Systems Engineer in Goleta, CA at Volt

Date Posted: 10/23/2018

Job Snapshot

  • Employee Type:
    Direct Hire
  • Location:
    Goleta, CA
  • Duration:
    N/A
  • Date Posted:
    10/23/2018
  • Job ID:
    145193
  • Contact Name
    Volt Branch
  • Phone
    (714)921-5472

Job Description

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 inAgile 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 RESPONSIBILITES: List other important functions that are secondary duties but may be time consuming.

  • 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, ABILITIES: What does a person in this position need to be able to do?

  • 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 within a 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.