Senior Mechanical Design Engineer – Medical Devices

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

Job summary

Nihon Kohden Orange Med is seeking aSenior Mechanical Design Engineer to lead and execute mechanical design and development for medical device products. You will work with cross-functional teams to ensure robust, manufacturable, and compliant designs throughout the lifecycle.

The role requires 7+ years of experience in mechanical design, strong SolidWorks skills, and familiarity with FDA requirements and design controls.

Qualifications

• Strong understanding of risk management in product design and development.
• Design for manufacturability (DFM) and GD&T proficiency.
• Proven ability to analyze, model, simulate, and test mechanical designs.

Responsibilities

• Lead mechanical design and development activities for medical device components and systems.
• Maintain design documentation across the product lifecycle per FDA and quality system requirements.
• Perform design verification and validation, develop test methods and analyses.
• Collaborate with QA, RA, manufacturing and suppliers to ensure regulatory compliance.

Skills

Risk management

Design for manufacturability

GD&T

Analytical thinking

Technical communication

Education

BS in Mechanical Engineering

Tools

SolidWorks

Job description

Nihon Kohden Orange Med is seeking aSenior Mechanical Design Engineer to lead and execute mechanical design and development for medical device products. You will work with cross-functional teams to ensure robust, manufacturable, and compliant designs throughout the lifecycle.

The role requires 7+ years of experience in mechanical design, strong SolidWorks skills, and familiarity with FDA requirements and design controls.