>
>COMPANY NAME: AEGEA Medical, Inc
>
> Redwood City, CA 94063
>
>TITLE: Medical Device Engineer (Hardware)
>
>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 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.
>
>• Plan, schedule and complete projects in an
>aggressive manner consistent with corporate objectives.
>
>• Support the development of the new design
>by analyzing the old design, creating
>performance criteria, and developing component
>specifications. Design new components as needed.
>
>• Design and perform experiments to perform evaluations.
>
>• Design and Develop unique testing protocols and fixtures.
>
>• Troubleshoot and repair hardware as needed
>and develop a maintenance plan.
>
>• Ensure integration with the disposable
>device and the requirements of the medical procedure.
>
>• Interface with and manage outside vendors,
>consultants and suppliers. Must be willing to
>travel to accomplish these tasks.
>
>• Support clinical cases and clinical trial
>duties as needed. Travel to clinical sites to
>set-up equipment and train personnel on use.
>
>• Contribute to the design control process
>with design discussion, development of
>specifications, creation and documentation of
>design information, and facilitating meetings.
>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, preferably MSME or MSEE
>
>• Minimum 3 years experience in medical device industry
>
>• Mechanical aptitude and troubleshooting skills
>
>• 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 clinicals/commercialization
>
>• Previous track record developing 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
- - - - - - - - - - - - - - - - - - -
Potential applicants should communicate directly
with the contact listed in the posting. Please
do not "reply" to the posting messages.
Job postings are archived at
http://design.stanford.edu/archive/
Note: The job postings distribution list
contains several distribution lists: Design grad
students, ME310 alumni, ME218 alumni, ME jobs
list, etc. Members of multiple lists will
receive multiple copies of postings. Please
excuse the duplication. Thank you.
Received on 2013-02-26 14:49:37