Senior Mechanical Engineer

ipgjobs; Marlborough (MA); On-site; USD 130,000 - 170,000; Full time

Job summary

ipgjobs is seeking a Senior Opto-Mechanical Engineer II for Medical Devices in Marlborough, MA. Lead design across development phases, collaborate with marketing and eng teams, and drive IP portfolio development while ensuring compliance with FDA/ISO13485 and CE marking standards.

The role requires extensive experience in laser/optical medical devices, strong project leadership, and hands-on SOLIDWORKS expertise with PDM. Will coordinate with partners and vendors and may travel up to 20%.

Qualifications

• 10+ years of mechanical design engineering in laser, optical and medical device industry.
• Strong knowledge of regulatory requirements for medical devices (FDA, ISO 13485).
• SolidWorks proficiency and experience with design history files.

Responsibilities

• Lead development of complex medical devices and subsystems through all development phases, coordinating with system requirements.
• Assist in developing IP portfolio and provide technical solutions to improve performance and cost.
• Develop product specifications with marketing, customers, and other departments.
• Coordinate transfer of products to customers or distributors, analyzing complaints and recommendations.
• Provide cost reduction programs for medical instruments.
• Ensure regulatory compliance (FDA, ISO 13485, CE mark) and maintain documentation for regulatory approval.
• Assist in design history file maintenance and manufacture readiness.
• Travel to interface with domestic partner and IPG facilities (<20%).

Skills

Mechanical design

Project management

SOLIDWORKS

Opto-mechanical design

Documentation

Cross-functional leadership

Education

MS in Mechanical Engineering

Regulatory knowledge (FDA/ISO13485)

SolidWorks expertise

Tools

SOLIDWORKS

PDM

MS Office

Job description

Senior Opto-Mechanical EngineerII-Medical Devices

Duties

• 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.
• Requires some travel to interface with domestic partner and regional IPG facility (<20%)

• * 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.
• * Apply knowledge of engineering principles to design components and mechanisms.
• * Experience with MS Office products (Word, Excel, PowerPoint, Project and Visio).

Education requirements

• MS in Mechanical Engineering or related field
• Strong knowledge of the engineering aspects of US and global regulatory requirements for medical devices
• Experienced Solidworks user.

Experience requirements

• 10+ years of work experience in research and development designing light based medical instrumentation and products, with more than 5 years in senior position of supervising technical part of development projects with internal and external teams, development partners and suppliers within a company operated under ISO 13485 and FDA protocol in all phases from design input to transfer to production;
• Extensive experience in development of optical systems including alignment, stability, packaging, tolerancing, and specifying optical components. Knowledge of optical materials, coatings, drawing practices.
• Experience with thermal management of optical systems including source cooling with air, fluid, TEC’s etc.
• Innovative approach in development of multi-functional medical instruments including mechanical / optical / electronic components and lab experimentation with breadboards.
• Coordination of development teams, work within strict time schedules and budget boundaries, managing multiple suppliers and development partners, negotiating specifications and technical terms of the projects;
• Successful records of rapid prototyping for pre-clinical and clinical studies.