Senior Opto-Mechanical Medical Device 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

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%.