Senior Mechanical Engineer - Medical Devices & NPD

Intellectt Inc; Dublin (CA); On-site; USD 110,000 - 165,000; Full time

Job summary

Intellectt Inc. is seeking an experienced mechanical design lead to drive electromechanical medical device development. You will own architecture, enclosures, mounts, and thermal paths, while delivering 3D CAD models, drawings, GD&T, and BOMs.

You will support prototyping, verification, validation, and production release, performing FEA, calculations, and design reviews. The role requires 8–12 years of medical device NPD experience, proficiency in SolidWorks or Creo, and strong GD&T with ASME

Qualifications

• 8–12 years of mechanical design/development experience in medical devices
• Bachelor’s or Master’s in Mechanical Engineering
• SolidWorks or Creo required
• Strong GD&T, ASME Y14.5, tolerance stack‑up, DFM/DFA, and FEA experience
• Experience with ISO 13485, FDA, ISO 14971, DHF and V&V

Responsibilities

• Lead mechanical design and development for electromechanical medical devices
• Own mechanical architecture, enclosures, mechanisms, mounts, thermal paths, and cable routing
• Develop 3D CAD models, drawings, GD&T, BOMs, and mechanical designs
• Support concept, prototyping, verification/validation, and production release
• Perform tolerance stack-ups, FEA, engineering calculations, and design reviews
• Support dFMEA/pFMEA, ECO/ECN, DFM/DFA, and design transfer
• Work with suppliers and cross‑functional Engineering, Quality, Regulatory, and Manufacturing teams

Skills

Medical Device NPD

Mechanical Design

SolidWorks/Creo

GD&T

ASME Y14.5

Tolerance Stack-Up

DFM/DFA

FEA

EMI/EMC

ISO 13485

FDA Knowledge

Windchill/Agile

Education

Bachelor’s or Master’s in Mechanical Engineering

Tools

SolidWorks

Creo

FEA Tools

Windchill

Job description

Intellectt Inc. is seeking an experienced mechanical design lead to drive electromechanical medical device development. You will own architecture, enclosures, mounts, and thermal paths, while delivering 3D CAD models, drawings, GD&T, and BOMs.

You will support prototyping, verification, validation, and production release, performing FEA, calculations, and design reviews. The role requires 8–12 years of medical device NPD experience, proficiency in SolidWorks or Creo, and strong GD&T with ASME