Senior Mechanical Design Engineer, Medical Devices Innovator

Nihon-Kohden; Santa Ana (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Nihon Kohden is seeking a Senior Mechanical Design Engineer to lead mechanical design and development activities for medical device products in a regulated environment. You will drive design, verification, and lifecycle support with cross-functional teams, applying SolidWorks and DFx to deliver robust, manufacturable solutions.

This role emphasizes independent leadership, risk management, and adherence to FDA requirements and design controls, with occasional domestic travel and opportunities to

Qualifications

• 7+ years of mechanical engineering design and development experience in medical devices or regulated industries.
• Proficient with SolidWorks or equivalent 3D CAD software.
• Experience with design controls, design verification, and design validation within regulated environments.

Responsibilities

• Lead mechanical design and development activities for medical device components, assemblies, and systems.
• Maintain design documentation throughout product lifecycle per DHF, FDA requirements, and quality procedures.
• Conduct analyses, simulations, prototyping, and testing to support design decisions and ensure compliance.

Skills

SolidWorks

DFx

Technical leadership

Risk analysis

Engineering documentation

Education

Bachelor's degree in mechanical engineering

Master's degree preferred

Tools

SolidWorks

Job description

Nihon Kohden is seeking a Senior Mechanical Design Engineer to lead mechanical design and development activities for medical device products in a regulated environment. You will drive design, verification, and lifecycle support with cross-functional teams, applying SolidWorks and DFx to deliver robust, manufacturable solutions.

This role emphasizes independent leadership, risk management, and adherence to FDA requirements and design controls, with occasional domestic travel and opportunities to