Senior Test Engineer - EE

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 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.
To find out more about Real please visit www.realstaffing.com