Mechanical Engineer – NPD

Hello,
I hope you are doing well!

This is Mahaboob from Intellectt Inc. I am reaching out regarding a job opportunity.
Please find the C2C requirements below and let me know if you have any profiles that match the requirements. Kindly share your updated resumes.

Job Title: Mechanical Engineer NPD
Location: Dublin, CA
Work Arrangement: Onsite
Experience: 8 12 Years
Duration: 12+months

Job Description: Seeking an experienced Mechanical Engineer NPD with strong expertise in medical device product development and electromechanical design. The ideal candidate will lead mechanical design activities from concept and prototyping through verification, design transfer, and production release.

Key Responsibilities

• Lead mechanical design and development for electromechanical medical devices.
• Own mechanical architecture for enclosures, mechanisms, mounts, thermal paths, cable routing, and component integration.
• Develop 3D CAD models, detailed drawings, GD&T, tolerance stack-ups, and BOMs using SolidWorks or Creo.
• Integrate motors, sensors, PCBs, batteries, connectors, power supplies, and cabling into mechanical assemblies.
• Perform FEA, engineering calculations, tolerance analysis, and design optimization.
• Lead dFMEA/pFMEA, hazard analysis, design reviews, and risk management.
• Support EVT, DVT, V&V testing, failure investigations, and design verification.
• Drive DFM/DFA, ECO/ECN, manufacturing support, and design transfer activities.
• Work with suppliers and contract manufacturers on tooling, materials, manufacturing processes, FAI, PPAP, and pilot builds.
• Support resolution of NCRs, deviations, manufacturing issues, and yield problems.
• Collaborate with Electronics, Software, Systems, Quality, Regulatory, and Supply Chain teams.
• Mentor junior engineers and provide technical leadership throughout the NPD lifecycle.

Required Skills

• 8 12 years of Mechanical Design & NPD experience.
• Strong Medical Device industry experience.
• Proficiency in SolidWorks or Creo.
• Strong electromechanical integration and mechanical architecture experience.
• GD&T / ASME Y14.5 and tolerance stack-up.
• DFM/DFA, FEA, and engineering calculations.
• Knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971, and FMEA.
• Experience with EVT/DVT, V&V, design transfer, and production release.
• Experience with ECO/ECN and PLM/QMS systems such as Windchill or Agile is preferred.
• Bachelor's or Master's degree in Mechanical Engineering.