SR Mechanical Engineer

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.

• 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.

• 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.