Staff Mechanical Engineer, Medical Devices & Opto-Systems

Cutera, Inc.; Raleigh (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

Cutera, Inc. is seeking a Staff Mechanical Engineer to join its R&D Mechanical Engineering team, developing advanced medical devices with precision opto-mechanical assemblies, thermal management, and structural frames for energy systems.

You’ll collaborate across Electrical, Laser, Clinical, Manufacturing, Quality, and Regulatory teams from concept to launch. You will drive DFx, manage GD&T and BOMs, own major subsystems, and mentor engineers while ensuring design records comply with FDA QMS and

Qualifications

• Bachelor’s degree in Mechanical Engineering; graduate degree preferred.
• 4-9+ years of relevant mechanical design experience, preferably in medical devices, lasers, or capital equipment.
• 5+ years of CAD design experience; SolidWorks preferred.
• Extensive knowledge of manufacturing technologies, including injection molding, sheet metal fabrication, and high-precision machining.
• Experience designing and assembling miniature optical components using solder, adhesives, and advanced fastening techniques for laser applications.
• Experience collaborating with clinical personnel to develop medical devices that meet ergonomic and usability requirements.
• Experience designing, assembling, and testing rapid-turn prototypes using rapid prototyping, machining, and off-the-shelf components.
• Strong understanding of GD&T principles and their application to precision mechanical designs.

Responsibilities

• Independently model, design, and detail high-precision mechanical parts, complex sub-assemblies, and dynamic opto-mechanical systems.
• Manage and structure large SolidWorks assemblies and multi-level BOMs from concept through pilot manufacturing.
• Ensure compliance with FDA Quality System Regulations within a QMS framework.
• Translate requirements into verifiable designs and draft design verification protocols.
• Design and optimize injection-m molded components and assemblies with biocompatible resins.
• Develop structural assemblies with metal frames and plastic covers, managing tolerances with GD&T.
• Collaborate with tooling vendors and contract manufacturers.
• Lead design reviews and mentor associate engineers.

Skills

CAD design

GD&T

Prototyping

FMEA

Thermal design

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical Engineering

Graduate degree preferred

Tools

SolidWorks

Excel

MATLAB

LabVIEW

Job description

Cutera, Inc. is seeking a Staff Mechanical Engineer to join its R&D Mechanical Engineering team, developing advanced medical devices with precision opto-mechanical assemblies, thermal management, and structural frames for energy systems.

You’ll collaborate across Electrical, Laser, Clinical, Manufacturing, Quality, and Regulatory teams from concept to launch. You will drive DFx, manage GD&T and BOMs, own major subsystems, and mentor engineers while ensuring design records comply with FDA QMS and