Mechanical Design Engineer J2B Global LLC Dublin, CA Job Details 22 hours ago Qualifications Medical device validation New product introduction engineering projects 3D modeling software Medical device testing ISO standards GD&T First article inspection 3D modeling for product design Quality risk management Design failure mode and effects analysis (DFMEA) ASME codes & standards Design engineering FEA Design for manufacturability (DFM) Biomedical regulatory compliance Hazard analysis Mechanical product validation projects Mechanical knowledge FDA regulations Structural analysis Full Job Description Mechanical Design Engineer ContractC2CW2 Dublin, CA -

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GC-EADH4-EADTNEAD

Job Summary:

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.

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. Bachelor's or Master's degree in Mechanical Engineering.

Desired Skills:

Experience with ECO/ECN and PLM/QMS systems such as Windchill or Agile is preferred. Refer