Senior Staff Mechanical Engineer, Medical Devices & Optics

Cutera-Inc; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Cutera-Inc in Raleigh, NC, seeks a Staff Mechanical Engineer to lead the design of precision opto-mechanical assemblies for next generation medical devices, spanning laser delivery, high-power ultrasound, and RF systems.

You will own subsystems from concept through verification, collaborate with electrical, laser, clinical, manufacturing, and quality teams, and drive DFx, GD&T, FMEA, and design controls within a FDA QMS framework.

Qualifications

• Bachelor's degree in Mechanical Engineering required; 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.

Responsibilities

• Independently model, design, and detail high-precision mechanical parts and opto-mechanical systems.
• Lead and mentor engineers; conduct peer CAD reviews ensuring GD&T.
• Collaborate with Systems, Electrical, and Embedded Software teams for interfaces.
• Drive DFx feedback loops for tool design, mold flow, and assembly workflows.
• Design and test fixtures; draft verification test procedures and execute tests.
• Ensure compliance with FDA QMS, Design Controls, and ISO 14971 risk management.

Skills

GD&T principles

Opto-mechanical design

FEA tools

Ergonomic usability design

Education

Bachelor’s degree in Mechanical Engineering

Graduate degree preferred

Tools

SolidWorks

FEA tools (e.g., ANSYS)

Job description

Cutera-Inc in Raleigh, NC, seeks a Staff Mechanical Engineer to lead the design of precision opto-mechanical assemblies for next generation medical devices, spanning laser delivery, high-power ultrasound, and RF systems.

You will own subsystems from concept through verification, collaborate with electrical, laser, clinical, manufacturing, and quality teams, and drive DFx, GD&T, FMEA, and design controls within a FDA QMS framework.