Our client in Marlboro, MA is looking to bring on a SR Opto-Mechanical Engineer. This is a direct hire opportunity with full benefits and a bonus.
Responsibilities
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.
Requirements
BSME, MSME preferred.
Minimum 8+ years of Mechanical Design Engineering experience in Laser, Optical and Medical Device Industry.
Strong project management & leadership skills and experience.
Experience with a 3D design tool, preferably SOLIDWORKS including PDM system.
Strong working knowledge of device packaging, opto-mechanical, interfacing with systems and electronics groups, & automation systems as a plus.
Apply knowledge of engineering principles to design components and mechanisms.
Strong knowledge of the engineering aspects of US and global regulatory requirements for medical devices.
Extensive experience in development of optical systems including alignment, stability, packaging, tolerancing, and specifying optical components. Knowledge of optical materials, coatings, drawing practices.