Senior Mechanical Engineer

Marlborough, Massachusetts, United States

Senior Opto-Mechanical Engineer II-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 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 (