Senior Mechanical Engineer

IPG Photonics • Marlborough, MA

1d

About The Position

The Senior Opto-Mechanical Engineer leads the development of complex medical devices and subsystems through all development phases, from design input through verification and validation to manufacturing transfer, while coordinating with overall system requirements. The role develops product specifications with marketing, customers, and other company departments; provides original technical solutions to improve product performance, functionality, reliability, and cost; supports development of the company’s intellectual property portfolio; and leads cost-reduction initiatives for medical instruments.

The engineer coordinates technical product transfers to customers or distributors, including analysis of customer complaints and recommendations. The role ensures products meet global medical-device regulatory requirements, including FDA regulations, ISO 13485, and CE marking, and supports the development and maintenance of design history files and other documentation required for regulatory approval and manufacturing.

The position involves leading engineering projects and development teams, working with internal and external teams, development partners, and suppliers, and coordinating with systems and electronics groups. Some travel is required to interface with domestic partners and a regional IPG facility (less than 20%).

Requirements

• At least 10 years of mechanical design engineering experience in the laser, optical, and medical-device industries.
• At least 10 years of research and development experience designing light-based medical instrumentation and products.
• More than 5 years in a senior position supervising the technical aspects of development projects with internal and external teams, development partners, and suppliers.
• Experience working within a company operating under ISO 13485 and FDA protocols, across phases from design input to transfer to production.
• Master’s degree in Mechanical Engineering or a related field.
• Strong knowledge of US and global regulatory requirements for medical devices.
• Strong project management and leadership skills.
• Experience with a 3D design tool; SolidWorks, including a PDM system, is preferred.
• Extensive experience developing optical systems, including alignment, stability, packaging, tolerancing, and specifying optical components.
• Knowledge of optical materials, coatings, and drawing practices.
• Experience with thermal management of optical systems, including source cooling using air, fluid, or TECs.
• Ability to direct, coordinate, and execute all phases of engineering projects, including planning, organization, execution, integration, and completion.
• Experience with MS Office products, including Word, Excel, PowerPoint, Project, and Visio.
• Ability to coordinate development teams, work within strict schedules and budget limits, manage suppliers and development partners, and negotiate specifications and technical terms.

Nice To Haves

• Bachelor’s degree in Mechanical Engineering; a Master’s degree is preferred.
• Experience with SolidWorks PDM.
• Knowledge of device packaging, opto-mechanical design, interfacing with systems and electronics groups, and automation systems.
• Innovative approach to developing multifunctional medical instruments incorporating mechanical, optical, and electronic components.
• Successful experience with rapid prototyping for pre-clinical and clinical studies.

Responsibilities

• Lead development of complex medical devices and subsystems from design input through verification, validation, and manufacturing transfer, in coordination with overall system requirements.
• Assist in developing the intellectual property portfolio for the instruments and provide original technical solutions to improve performance, functionality, reliability, and cost.
• Develop product specifications in coordination with marketing, customers, and other company departments.
• Coordinate the technical aspects of transferring company products and instruments to customers or distributors, including analyzing customer complaints and making recommendations.
• Provide cost-reduction programs for medical instruments.
• Ensure products are designed to meet global medical-device regulatory requirements, including FDA regulations, ISO 13485, and CE marking.
• Assist in developing and maintaining design history files and other documentation supporting product regulatory approval and manufacture.
• Plan, organize, execute, integrate, and complete engineering projects.
• Apply engineering principles to design components and mechanisms.
• Supervise the technical aspects of development projects involving internal and external teams, development partners, and suppliers.
• Coordinate development teams and manage schedules, budgets, suppliers, development partners, and project specifications and technical terms.
• Conduct laboratory experimentation with breadboards and support rapid prototyping for pre-clinical and clinical studies.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior