Staff Opto-Mechanical Engineer – Medical Devices & Lasers

Cutera; Raleigh (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

Cutera in Raleigh, NC seeks a Staff Mechanical Engineer for our R&D team to develop medical devices including laser, optical delivery, ultrasound, and RF systems. You will design opto-mechanical assemblies, thermal management, and industrial housings from concept through launch with cross-functional collaboration.

You will mentor associates, lead design reviews, drive DFM feedback, and ensure compliance with FDA QMS, Design Controls, and ISO 14971 risk management.

Qualifications

• Bachelor’s degree in Mechanical Engineering; graduate degree preferred.
• 4–9+ years of mechanical design experience, preferably in medical devices or capital equipment.
• 5+ years of CAD design experience; SolidWorks preferred.
• Experience with injection molding, sheet metal, and high-precision machining.

Responsibilities

• Model, design, and detail high-precision mechanical parts and opto-mechanical systems.
• Manage large SolidWorks assemblies and multi-level BOMs from concept to pilot.
• Ensure QMS compliance, design records, and FDA Design Controls documentation.
• Lead design reviews and mentor associates; communicate progress to management.
• Develop and test fixtures; perform design verification testing and risk assessments.
• Collaborate with Systems, Electrical, and Software teams on interfaces.

Skills

GD&T principles

CAD design

SolidWorks

FEM / simulation

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

FEA tools

Job description

Cutera in Raleigh, NC seeks a Staff Mechanical Engineer for our R&D team to develop medical devices including laser, optical delivery, ultrasound, and RF systems. You will design opto-mechanical assemblies, thermal management, and industrial housings from concept through launch with cross-functional collaboration.

You will mentor associates, lead design reviews, drive DFM feedback, and ensure compliance with FDA QMS, Design Controls, and ISO 14971 risk management.