Senior Mechanical Engineer

The Judge Group; Marlborough (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

The Judge Group is seeking an experienced Mechanical Design Engineer to lead development of complex medical devices from design input through transfer to manufacturing. You will collaborate with marketing, customers and other departments to define specifications and drive cost-reduction initiatives while ensuring regulatory compliance.

Ideal candidates have 10+ years in laser/optical/medical device design, strong leadership and SOLIDWORKS/PDM experience, and ability to coordinate

Qualifications

• BSME required; MSME preferred.
• 10+ years mechanical design engineering experience in laser, optical, medical device industry.
• Strong project management and leadership skills.
• Experience with 3D design tool, preferably SOLIDWORKS including PDM system.
• Knowledge of device packaging, opto-mechanical interfaces, and automation systems a plus.

Responsibilities

• Lead development of complex medical devices and subsystems through all development phases from design input through verification and validation to manufacturing transfer stages.
• Assist in developing company portfolio for these instruments and provide original technical solutions to improve performance, functionality, reliability and costs.
• 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 and assure products meet global regulatory requirements (FDA regulations, ISO 13485, CE mark).

Skills

Project management

Leadership

Cross-functional coordination

Problem solving

Communication

Education

BSME

MSME preferred

Tools

SOLIDWORKS

PDM

Job description

The ideal candidate will be responsible for maintaining product and industry knowledge. You will work in a team-oriented environment that accelerates operational efficiency.

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 company 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 and 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.

Qualifications

• BSME, MSME preferred.
• Minimum 10 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
• Ability to direct, coordinate and execute all phases including planning, organization, execution, integration and completion of engineering projects.