Mechanical Design Engineer

🔧 We’re Hiring: Mechanical Design Engineers

📍 Location: Palo Alto, California

📅 Duration: Long-Term Contract

Title: Mechanical Design Engineer

Location: Palo Alto, California

JD:

• Design mechanical components, assemblies, and systems for medical devices from concept to production using Creo & SolidWorks.
• Hands-on experience in PDM / PLM (SAP-ECTR) for managing lifecycle of the components, managing ECO / ECR (SAP).
• Build and test prototypes to validate design performance against specifications and ensure safety and reliability.
• Select appropriate materials by considering factors critical in the medical industry, such as biocompatibility, sterilization compatibility, and cost-effectiveness.
• (DFM/DFA): Designs are optimized to ensure they can be efficiently produced and assembled, considering manufacturing processes.
• Using advanced CAD software such as Creo or SolidWorks, create detailed 2D drawings of components and assemblies.
• Apply Geometric Dimensioning and Tolerancing (GD&T) to communicate design tolerances and specifications precisely for accurate manufacturing.
• Generate and maintain the BOM, which is a comprehensive list of all raw materials, components, and assemblies needed to manufacture the final product.
• Organize and maintain a comprehensive Design History File (DHF), which documents the entire design process, including inputs, outputs, verification, and validation records.
• Revising and updating technical drawings and documentation as needed and for managing the engineering change order (ECO) process.
• Ensuring all design and documentation adheres to strict medical device regulations from bodies like the FDA and standards like ISO 13485.
• Work with a range of professionals, including quality assurance, regulatory affairs, manufacturing and sourcing, to bring a product from concept to launch.

Title: Senior Mechanical Design Engineer(8+ Years)

Location: Palo Alto, California

JD:

• Lead mechanical subsystem development from concept and requirements through detailed design, prototyping, testing, and release
• Strong hands-on experience with 3D CAD, engineering drawings, GD&T, tolerance stack-up, material selection, and DFM/DFA.
• Experience designing mechanisms, precision assemblies, structures, enclosures, motion systems, or electromechanical products.
• Apply engineering analysis for structural, thermal, vibration, fatigue, and reliability considerations as applicable.
• Translate product/system requirements into practical and manufacturable mechanical designs.
• Support system integration and resolve mechanical, electrical, manufacturing, and interface-related issues.
• Develop engineering test methods and support design verification activities.
• Select appropriate materials by considering factors critical in the medical industry, such as biocompatibility, sterilization compatibility, and cost-effectiveness.
• Drive prototype builds, design iterations, testing, troubleshooting, and root-cause analysis.
• Participate in design reviews, risk analysis/FMEA, Design Controls, V&V, and design transfer activities.
• Collaborate with Systems, Electrical, Software, Quality, Regulatory, Manufacturing, and suppliers.
• Experience supporting early-stage product development, rapid prototyping, and technology maturation is preferred