Senior Mechanical Engineer

IPG Photonics•Marlborough, MA

89d

About The Position

The Senior Mechanical Engineer leads the development of complex medical devices and subsystems through all development phases, from design inputs through verification and validation to manufacturing transfer, in coordination with overall system requirements. The role contributes to intellectual property development and creates technical solutions to improve product performance, functionality, reliability, and cost. It develops product specifications with marketing, customers, and other departments; supports product transfers to customers and distributors; and provides technical analysis of customer complaints and recommendations. The position supports cost-reduction programs and ensures products meet global medical-device regulatory requirements, including FDA regulations, ISO 13485, and CE marking. It also assists with design history files and other documentation needed for regulatory approval and manufacturing. The role requires some travel 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 industry.
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 through all development phases, from design input to transfer to production, within a company operating under ISO 13485 and FDA protocols.
Strong project management and leadership skills.
Ability to direct, coordinate, and execute all phases of engineering projects, including planning, organization, execution, integration, and completion.
Experience with a 3D design tool; SOLIDWORKS, including its PDM system, is preferred.
Experienced SOLIDWORKS user.
Strong knowledge of device packaging and opto-mechanical design, and experience interfacing with systems and electronics groups.
Strong knowledge of the engineering aspects of U.S. and global regulatory requirements for medical devices.
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 with air, fluid, or TECs.
Ability to coordinate development teams, work within strict schedules and budget boundaries, manage multiple suppliers and development partners, and negotiate project specifications and technical terms.
Experience with MS Office products, including Word, Excel, PowerPoint, Project, and Visio.

Nice To Haves

Master's degree in Mechanical Engineering or a related field.
Experience with automation systems.
Experience using SOLIDWORKS and its PDM system.

Responsibilities

Lead development of complex medical devices and subsystems from design input through verification, validation, and manufacturing transfer, coordinated 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 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 regulatory approval and manufacturing.
Direct, coordinate, and execute engineering project phases, including planning, organization, execution, integration, and completion.
Apply engineering principles to design components and mechanisms.
Coordinate development teams, schedules, budgets, suppliers, and development partners, and negotiate project specifications and technical terms.
Develop optical systems, including alignment, stability, packaging, tolerancing, and specification of optical components.
Support thermal management of optical systems, including source cooling using air, fluid, or TECs.
Develop multifunctional medical instruments incorporating mechanical, optical, and electronic components, including laboratory experimentation with breadboards.
Perform rapid prototyping for pre-clinical and clinical studies.
Travel as needed to interface with domestic partners and a regional IPG facility (less than 20%).