Senior Staff Mechanical Engineer, Medical Devices & Optics

Cutera, Inc.; Raleigh (NC); On-site; USD 140,000 - 210,000; Full time

Job summary

Cutera, Inc. is seeking an exceptional Senior Staff Mechanical Engineer to join our R&D Mechanical Engineering team and drive development of advanced medical devices.

You will design opto-mechanical assemblies, thermal management systems, and robust frames for energy systems, collaborating with electrical, laser, clinical, and regulatory teams from concept to launch. The role requires extensive SolidWorks experience, deep GD&T and FEA knowledge, and strong cross-functional leadership within a

Qualifications

• Bachelor's degree in Mechanical Engineering; graduate degree preferred.
• 10+ years of relevant mechanical design experience in medical devices or capital equipment.
• Extensive CAD experience; SolidWorks preferred.
• Experience with injection molding, sheet metal fabrication, and high-precision machining.
• Experience designing optical components for laser applications.
• Strong GD&T knowledge and use of FEA tools with test data correlation.
• Experience with thermal management, actuation assemblies, and opto-mechanical design.
• Familiarity with FDA QSR, Design Controls, IEC60601, ISO14971; cross-functional collaboration.
• Proficient with Excel, MATLAB, and data analysis tools; strong communication.

Responsibilities

• Owns system-level Design Verification and Validation strategies.
• Lead risk management per ISO 14971 and ensure compliance with IEC 60601.
• Define master tolerance strategy and structural layout for global standards.
• Lead vendor selection and CM collaboration; resolve production scaling challenges.
• Define mechanical testing framework and complex test fixtures.
• Architect multi-subsystem layouts using SolidWorks.
• Enforce design best practices and GD&T across the team.
• Drive QMS compliance through FDA requirements and design controls.
• Mentor and develop engineering capability within the team.

Skills

SolidWorks

GD&T

FEA

Thermal management

Opto-mechanical

Cross-functional

Medical devices

Laser optics

Prototype testing

Design controls

Education

Bachelor's in Mechanical Engineering

Graduate degree preferred

Tools

LabVIEW

Excel

MATLAB

Job description

Cutera, Inc. is seeking an exceptional Senior Staff Mechanical Engineer to join our R&D Mechanical Engineering team and drive development of advanced medical devices.

You will design opto-mechanical assemblies, thermal management systems, and robust frames for energy systems, collaborating with electrical, laser, clinical, and regulatory teams from concept to launch. The role requires extensive SolidWorks experience, deep GD&T and FEA knowledge, and strong cross-functional leadership within a