Senior Mechanical Design Engineer – Medical Devices(NPD)

Intellectt Inc; Dublin (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Intellectt Inc. seeks a Technical Lead for Mechanical Design to own the mechanical architecture of electromechanical medical device programs. You will drive end-to-end design from concept through production release, integrating electrical and software constraints for robust, compliant solutions.

You will support regulated development with verification/validation, design transfer, and supplier collaboration, while mentoring teams and leading design reviews to improve products and processes.

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering.
• 8–12 years of mechanical design & development experience.
• Significant experience in Medical Device NPD.
• Proven experience leading electromechanical product development through full lifecycle in regulated environments.
• Experience leading technical discussions, design reviews, customer walkthroughs, and cross-functional collaboration.
• Experience supporting FAI, PPAP, pilot builds, design transfer, manufacturing issues, NCRs, deviations, and supplier/contract manufacturer activities.

Responsibilities

• Lead end-to-end mechanical design across enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.
• Own mechanical architecture and interfaces, integrating electrical and software constraints.
• Support regulated product development through verification, validation, design transfer, and manufacturing collaboration.
• Drive continuous design improvement and successful production release after design freeze.

Skills

Mechanical architecture

EMI/EMC-aware design

Cross-functional collaboration

DFM/DFA

Education

Bachelor’s or Master’s in Mechanical Engineering

Tools

SolidWorks

Creo

3D CAD

GD&T

FEM/FEA

Job description

Act as the Technical Lead for Mechanical Design within electromechanical medical device programs, owning mechanical architecture and interfaces across enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations. Lead end-to-end mechanical design from concept, feasibility, and prototyping through design freeze and production release, while integrating electrical and software constraints into robust mechanical designs. Support regulated product development through verification, validation, design transfer, manufacturing, supplier collaboration, and continuous design improvement.

Key Skills

• Mechanical architecture, electromechanical integration, enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC-aware design
• SolidWorks or Creo, 3D CAD, detailed drawings, GD&T, ASME Y14.5, BOMs, tolerance stack-ups, FEA, and engineering calculations
• Medical device NPD, DFM/DFA, reliability engineering, materials and manufacturing processes, tooling, pilot builds, and production release
• ISO 13485, FDA 21 CFR 820, ISO 14971, DHF, dFMEA/pFMEA, hazard analysis, ECO/ECN, EVT/DVT, V&V, design transfer, and PLM/QMS including Windchill or Agile

Required Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering
• 8–12 years of Mechanical Design & Development experience
• Significant experience in Medical Device NPD
• Proven experience leading electromechanical product development through the full product lifecycle in regulated environments
• Experience leading technical discussions, design reviews, customer walkthroughs, and cross-functional collaboration
• Experience supporting FAI, PPAP, pilot builds, design transfer, manufacturing issues, NCRs, deviations, and supplier/contract manufacturer activities

Additional Skills

• Experience integrating motors, sensors, PCBs, batteries, power supplies, connectors, and cabling
• Experience with thermal considerations, EMI/EMC, reliability engineering, and manufacturing process improvement
• Experience with supplier and contract manufacturer management, tooling, materials, processes, and yield improvement
• Experience with cost reduction, design optimization, next-generation improvements, and mentoring junior and mid-level engineers