COMPANY NAME: AEGEA Medical, Inc
Redwood City, CA 94063
TITLE: Medical Device Engineer (Mechanical)
SUMMARY: The Company is developing a
novel energy delivery system for women’s health.
The system consists of a re-usable hardware “box”
and a disposable hand-piece. The hand-piece is
designed and fabricated in house. The hardware
box was designed by an outside vendor and
contains mechanical elements, fluid pathways,
electronics and programmable software. The
company needs help to upgrade the hardware box,
to transfer the design from the development house
to a manufacturer, to verify and validate the
box, to support FDA submissions, and to support
clinical trials. The Company will consider a wide
range of experience and will adjust
responsibilities and compensation accordingly.
Purpose of Job: Drive the development efforts
for the Company’s reusable hardware box and
provide technical support for clinical trials.
Essential Functions:
• Support R&D’s efforts by providing
engineering services, project management and vendor oversight.
• Troubleshoot and repair mechanical hardware
(piping, valves, connectors, etc.) as needed and develop a maintenance plan.
• Support clinical cases and clinical trial
duties as needed. Travel to clinical sites to
set-up equipment and train personnel on use.
• Interface with and manage outside vendors,
consultants and suppliers. Must be willing to
travel to accomplish these tasks.
• Design and perform experiments.
• Design and develop unique testing protocols and fixtures.
• Ensure integration with the disposable
device and the requirements of the medical procedure.
• Plan, schedule and complete projects in an
aggressive manner consistent with corporate objectives.
• Continue the development of the new design
by analyzing the existing design, creating
performance criteria, and developing component
specifications. Design new components as needed.
• Contribute to the design control process
with design discussion, development of
specifications, creation and documentation of
design informatios. Responsible for developing
and populating DHF’s for projects.
• Ensure project documents, processes and
capabilities are complete and current and that
they comply with Quality Systems and Regulatory requirements.
Job Requirements
• Bachelors in Engineering. Although the job
is mechanically focused, persons with EE background will be considered
• Minimum 3 years experience in medical device industry
• Mechanical aptitude, troubleshooting skills, and use of hand tools.
• Strong interpersonal and communication skills
• Team player with proven track record in start-up environment
Additionally, the ideal candidate has the following:
• Demonstrated experience managing medical
device projects involving outside suppliers
through clinical trials/commercialization
• Previous track record working with software controlled medical devices.
• Leadership skills and judgment to drive R&D
efforts through the full cycle of developing and
delivering a PMA medical device to market
• Strong knowledge and practical application
of FDA QSR’s, design control process,
verification and validation testing, DHF construction and execution.
• Understanding of IEC 60601 Electrical Safety and EMC requirements.
PLEASE SEND US:
• A short cover letter showing your
interest and what you would bring to the position
• Resume
• Send to:
o Fax Number: 650/701-1126
o Email: <mailto:aegeamedical_at_gmail.com>aegeamedical_at_gmail.com
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Received on 2013-11-05 14:32:58