Senior Opto-Mechanical Engineer - Medical Devices R&D

Cutera-Inc; Raleigh (NC); Sur place; USD 160 000 - 230 000; Plein temps

Résumé du poste

Cutera-Inc is seeking a Senior Staff Mechanical Engineer to join the R&D Mechanical Engineering team. You will lead design and development of opto-mechanical assemblies, structural frames, and thermal management for advanced medical devices, spanning laser, ultrasound, and RF technologies.

The role emphasizes V&V strategy, ISO 14971 risk management, and regulatory compliance (FDA/IEC 60601). Collaboration with Electrical, Laser, Clinical, Manufacturing, Quality, and Regulatory teams is central

Qualifications

• Bachelor’s degree in Mechanical Engineering; 10+ years in medical devices or capital equipment.
• Strong CAD design experience with SolidWorks and GD&T standards.
• Experience with manufacturing: injection molding, sheet metal, high-precision machining.

Responsabilités

• Own the mechanical design verification and validation strategy.
• Lead system-level risk management per ISO 14971 and comply with IEC 60601.
• Define structural platforms and master tolerance strategy for rugged products.
• Lead vendor selection and coordinate contract manufacturers for scale-up.
• Develop testing frameworks, fixtures, and regression plans across platforms.

Connaissances

SolidWorks

GD&T

Cross-functional collaboration

Formation

Bachelor’s degree in Mechanical Engineering

MS preferred

Outils

Finite Element Analysis (FEA) tools

Description du poste

Cutera-Inc is seeking a Senior Staff Mechanical Engineer to join the R&D Mechanical Engineering team. You will lead design and development of opto-mechanical assemblies, structural frames, and thermal management for advanced medical devices, spanning laser, ultrasound, and RF technologies.

The role emphasizes V&V strategy, ISO 14971 risk management, and regulatory compliance (FDA/IEC 60601). Collaboration with Electrical, Laser, Clinical, Manufacturing, Quality, and Regulatory teams is central