Senior Mech Engineer - Medical Devices & Opto-Systems

Cutera; Raleigh (NC); On-site; USD 150,000 - 200,000; Full time

Job summary

Cutera is seeking a Senior Staff Mechanical Engineer to join our R&D Mechanical Engineering team, focusing on the development of advanced medical devices and related applications. You will work on opto-mechanical assemblies, high-precision metal chassis, and cosmetic enclosures, collaborating closely with Electrical, Laser, Clinical, Manufacturing, and Quality groups.

The role emphasizes system-level V&V, risk management (ISO 14971), and adherence to FDA QMS and IEC 60601 standards, with

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent.
• 10+ years of relevant mechanical design experience in medical devices or related field.
• Strong CAD experience, SolidWorks preferred.
• Knowledge of manufacturing technologies including injection molding and precision machining.
• Experience with opto-mechanical assemblies and laser applications.
• Familiarity with FDA QSR, IEC 60601, and ISO 14971 risk management.

Responsibilities

• Own system-level mechanical design verification and validation strategy.
• Lead design reviews and cross-functional collaboration across engineering teams.
• Define master tolerance strategy and structural layout for durability and cosmetic quality.
• Oversee vendor selection and contract manufacturing standards.
• Develop testing framework including fixtures and qualification procedures.
• Lead root-cause investigations for complex mechanical issues.
• Apply SolidWorks for multi-subsystem layouts and top-down architecture.
• Enforce GD&T and advanced modeling practices within the team.
• Support regulatory and quality activities to meet medical safety standards.

Skills

Mechanical design

Cross-functional collaboration

GD&T

FMEA/ISO 14971

Thermal management

FEA

Opto-mechanical integration

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Excel

MATLAB

LabVIEW

Job description

Cutera is seeking a Senior Staff Mechanical Engineer to join our R&D Mechanical Engineering team, focusing on the development of advanced medical devices and related applications. You will work on opto-mechanical assemblies, high-precision metal chassis, and cosmetic enclosures, collaborating closely with Electrical, Laser, Clinical, Manufacturing, and Quality groups.

The role emphasizes system-level V&V, risk management (ISO 14971), and adherence to FDA QMS and IEC 60601 standards, with