Description
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