Senior Mechanical Engineer

Senior Mechanical Engineer - Medical Devices

Duties:

Lead development of complex medical devices and subsystems through all development phases from design input through verification and validation to manufacturing transfer stages and in coordination with overall system requirements.

Assist in developing IP portfolio for these instruments and provide original technical solutions to improve performance, functionality, reliability, costs, and requirements.

Develop product specification in coordination with marketing, customers, and other company departments.

Coordinate technical part of transfer of company products and instruments to customers or distributors, including analysis of customer complaints and recommendations.

Provide cost reduction program for medical instruments.

Assure products are designed to meet stringent global regulatory requirements of medical devices, such as FDA regulations, ISO 13485 CE mark for medical product, and others.

Assist in development and maintaining of design history file and other documentation to support product regulatory approval and manufacture.

Requires some travel to interface with domestic partner and regional IPG facility (<10)