Mechanical Engineer Npd

Mechanical Engineer NPD | Dublin, CA
Work Mode: 100% Onsite
Experience: 5+ years

Required Skills:
5+ years of Mechanical Design & New Product Development (NPD)
Medical device product development experience
Proficiency in SolidWorks or Creo and 3D CAD design
GD&T (ASME Y14.5), tolerance stack-up, and FEA
Electromechanical integration, thermal analysis, and EMI/EMC-aware design
DFM/DFA, prototyping, and design verification
Knowledge of ISO 13485, FDA regulations, ISO 14971, and FMEA
Experience with PLM/QMS tools such as Windchill or Agile

Key Responsibilities:
Lead mechanical design from concept and prototyping through validation and production release.
Design mechanisms, optical mounts, enclosures, chassis, and mechanical assemblies.
Perform tolerance analysis, stress/thermal analysis, and engineering calculations.
Integrate mechanical, electrical, and electronic components into product designs.
Lead design reviews, FMEA, and design verification activities.
Collaborate with suppliers, manufacturing, quality, and cross-functional teams.
Prepare engineering documentation and support pilot builds and design transfer to manufacturing.
Resolve design and manufacturing issues and drive cost and design optimization.

Preferred Qualifications:
Bachelor's or Master's degree in Mechanical Engineering
Experience with medical instruments, optics, or diagnostic equipment
Knowledge of injection molding, die-casting, sheet metal, and machining processes
Experience with ECO/ECN, BOMs, supplier coordination, and manufacturing transfer