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Date: 20 November 2008
Google
 
System-Regulatory Engineer
Category:

Description

Location: US-UT-Salt Lake City

  • Base Pay: N/A
  • Employee Type: Full-Time Employee
  • Industry: Healthcare - Health Services/Biotechnology/Pharmaceutical
  • Manages Others: No
  • Job Type: Engineering/Information Technology
  • Req'd Education: 4 Year Degree
  • Req'd Experience: At least 5 year(s)
  • Req'd Travel: Not Specified
  • Relocation Covered: No
  • Responsibilities:
  • Lead and drive the definition & the design of the System Applications needed for the medical uses (Features) of the GE Healthcare Global Surgery Products including (Fluoroscopic & Surgical Navigation) platforms for both short and long term to meet business needs.
  • Work closely with other functional areas (e.g. Marketing, Engineering, Manufacturing, Service) and mainly with the QA-RA department to ensure compliance to applicable regulations in the to system design and verifications.
  • Provide senior coaching and mentoring with key data from RA to help drive decisions on the system design and V&V.
  • Execute the design related to the System Applications for new or enhanced products with the use of the Design for Six Sigma (DFSS) process to pursue the right solutions.
  • Manage and/or create documentation related to the system applications for new or enhanced products.
  • Collaborate with the Sub-Systems Design Team to define, develop and implement a robust, flexible technical architecture to support the design of the applications.
  • Clearly communicate technical issues to engineering and non-engineering departments (Customers, Marketing, Sales, Service, Manufacturing.)
  • Be responsible for the use and the deployment of the Quality processes (Design Control,) for concept and design activities related to the development of the System Design.
  • Be involved in the technical reviews of design proposals and project reports.
  • Remain knowledgeable and in compliance with all company Environmental, Health and Safety practices and proactively address EHS issues that exist within the employee's immediate work environment.
  • Complete assignments and projects as identified by the department manager.
  • Team effectively with cross-functional members.
  • Work with unyielding personal integrity
  • Lead the system design to ensure products meet regulatory requirements
  • Qualifications:

  • Bachelors of Science degree in computational sciences, Electrical Engineering, Mechanical Engineering, Mathematics or Engineering.
  • Minimum of 5 years experience in medical imaging system design or equivalent.
  • At least 10 years of experience working in an FDA regulated Environment
  • Proven communication skills -- verbal & written.
  • Team player able to work closely with a global team and open to sharing information and best practices with the team.

    You must be willing to submit to a background investigation, including for example, verification of past employment, criminal history and educational background.
    You must be willing to take a drug test.

    Desired:

    - Masters of Science Degree preferred in computational sciences, Electrical Engineering, Mechanical Engineering, Mathematics or Engineering.

  • Knowledgeable in Medical Imaging engineering, generation of X-ray, and Human Interface for medical equipment.
  • An impact player with proven ability to drive change in an effective and participative manner in a global environment
  • Strong business acumen as well as customer focused influencing skills
  • Resourceful, innovative, persuasive
  • Demonstrated GE leadership values
  • Understanding of regulated Healthcare industry
  • Six sigma/ 5S/ Lean trained

    General:

    GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare's expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients.

    GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. GE is an equal opportunity employer.
    GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation.

    The United States has regulations that govern the hiring of current or former U.S. Government employees. If you currently work for (or have in the past) the U.S. Government (in any capacity), you may have certain responsibilities under these regulations and certain restrictions may apply to your potential employment with GE. Therefore, if you are contacted by GE regarding a position of employment, and you have worked for the U.S. Government at any time, please immediately inform the GE representative of this fact.

    Category: System Engineering Jobs

    Country: United States

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