CLINICAL ENGINEERING TECHNICIANS (CET, 2) - Austin & Houston, Texas Area.
Summary: This individual will be responsible for operating prototype,
noninvasive, light based, clinical data collection systems and
pre-production and production units of same in conjunction with client
physicians and nurse practitioners. The CET will operate systems in
laboratories at the Austin facilities, and in gynecological laboratories
and clinics in Houston and other national sites. The CET will be trained
in the operation of multiple systems types, will perform minor maintenance
and troubleshooting, will collect clinical data and device performance
data, and will be responsible for efficient data storage and transmission.
The individual will be trained to perform under ISO 9000, Good Clinical
Practice (GCP), Good Laboratory Practice (GLP), current Good Manufacturing
Practice (GMP), and other relevant, world-class medical device performance
standards. As a representative of the company, the CET will interact
daily with patients, physicians, scientists, vendors and team members
while maintaining a professional demeanor and appearance.
Duties and Responsibilities (successful candidates will have experience
with each of the following items):
* Learn the operation and limited troubleshooting of prototype photonic
clinical systems
* Learn relevant aspects of Design Control, learn regulations of the
federal Food and Drug Administration (FDA), cGMP, GCP, GLP
and learn and apply company Standard Operating Procedures (SOPs)
* Operate prototype diagnostic devices in a clinical setting in accordance
with training
* Collect patient data as required using Clinical Data Collection forms
* Observe performance of equipment in the hands of clinical users
* Observe patient interaction with the patient contact system
* Decontaminate patient contact systems
* Prepare detailed written reports of operator and patient interaction
with systems
* Prepare written design suggestions and performance reports for equipment
designers
* Perform and document equipment experiments with animal tissue, human
tissue, and optical models
* Collect, store and transmit digital data files
* Interact with clinical specialists and patients as part of a clinical
research team
* interact with suppliers and contractors with purchase orders,
confidentiality agreements, contracts, drawings, e-mail, fax and
phone communications
* Operate diagnostic devices in compliance with the laws and regulations
of the United States and the FDA
* Protect patient confidentiality in conformance with the requirements of
the Department of Health and Human Services and the
FDA
Minimum Qualifications Include:
Education: At least a four-year degree in Biology, Engineering, Nursing,
Medical Laboratory Technology or physical sciences. Advanced degree
holders in these fields and particularly in the fields of engineering are
encouraged to apply.
Specialized Skills and Knowledge Required:
* Familiarity with learning and complying with regulations. FDA, ISO 9000,
cGMP, GLP, and GCP knowledge is essential.
* Familiarity with operating and minor troubleshooting of optical elements
such as fiber optics, lenses and mirrors, lamps and
lasers. Skill in the use of power meters or spectrometers is essential.
* Familiarity with operating and minor troubleshooting of electronic
instruments. Previous experience with or skill in the use of
an oscilloscope is essential.
* Meticulous documentation skills, including familiarity with
specifications, experiment reports or lab notebooks and purchase
orders. Skill in data file management and data manipulation.
* Skill in the use of Microsoft Word and Excel. Skill in transferring data
on the Internet. Skill in the use of Labview or Matlab
would be beneficial.
Experience Required:
* Experience working in a rapid paced environment, self-supervising,
setting and performing priorities, and communicating
efforts and results to other members of a Project Team.
* Experience in verbal and written communication with physicians,
patients, professionals and suppliers.
* Experience with data file collection, creation, transfer, manipulation
and storage.
* Experience with equipment calibration logging, patient data accrual and
spread sheet use.
* The individual will be required to maintain a professional appearance at
all times.
LOCATION: Duties will be performed in laboratories at Austin, Texas about
three days per month. Initial training may require two weeks in Austin,
Texas . Most of the duties will be performed in hospital settings in
Houston, Texas. Some future travel including short term assignments will
be required to train and support equipment operators in other cities in
the U.S. and overseas. The are no relocation expenses available for this
position. Please send your resume to:
David W. Walters, Ph.D.
Senior Scientific Recruiter
ScienStaff, Inc.
ssihouston at aol.comhttp://www.net-solutions.com/ScienStaff
7007 Gulf Freeway, Suite 239
Houston, Texas 77087
Phone: 713-640-1929, FAX: 713-640-1942
