Mechanical Engineer – Medical Devices

Tap Growth ai; Palo Alto (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

Tap Growth ai is seeking a Mechanical Engineer to design, develop, prototype, and verify mechanical and electromechanical components for Class III medical devices, supporting development through production release.

You will create detailed CAD models and prototypes, perform calculations and tests, and collaborate with vendors to ensure manufacturability and quality while supporting 510(k) regulatory submissions.

Qualifications

• Bachelor’s or master’s degree in Mechanical Engineering or equivalent.
• 5+ years of relevant experience with a bachelor’s degree, or 3+ years with a master’s degree.
• Proficiency in SolidWorks and Creo.
• Strong knowledge of mechanical design, 3D CAD modeling, GD&T, and tolerance analysis.
• Knowledge of materials, finishes, and fabrication processes.
• Experience with electromechanical assemblies, prototyping, and manufacturing.
• Experience in component testing and design verification.

Responsibilities

• Design mechanical and electromechanical components for Class III medical devices.
• Develop subsystem requirements and identify potential failure modes.
• Create detailed mechanical designs and 3D CAD models.
• Develop prototypes and evaluate manufacturing processes.
• Perform mechanical calculations, design analysis, and testing.
• Develop and execute component verification and performance test protocols.
• Collaborate with vendors on manufacturing feasibility and quality.
• Support regulatory documentation for 510(k) submissions.
• Investigate product complaints and mechanical failures.
• Manage component development through production release.

Skills

SolidWorks

Creo

3D CAD

GD&T

Tolerance analysis

Materials

Protototyping

Electromechanical

Design verification

Testing

Education

Bachelor’s or Master’s in Mechanical Engineering

Tools

SolidWorks

Creo

Job description

Seeking a Mechanical Engineer to design, develop, prototype, and verify mechanical and electromechanical components for Class III medical devices, supporting development through production release.

Key Responsibilities

• Design mechanical and electromechanical components for Class III medical devices.
• Develop subsystem requirements and identify potential failure modes.
• Create detailed mechanical designs and 3D CAD models.
• Develop prototypes and evaluate manufacturing processes.
• Perform mechanical calculations, design analysis, and testing.
• Develop and execute component verification and performance test protocols.
• Collaborate with vendors on manufacturing feasibility and quality.
• Support regulatory documentation for 510(k) submissions.
• Investigate product complaints and mechanical failures.
• Manage component development through production release.

Required Qualifications and Skills

• Bachelor’s or master’s degree in Mechanical Engineering or equivalent.
• 5+ years of relevant experience with a bachelor’s degree, or 3+ years with a master’s degree.
• Proficiency in SolidWorks and Creo.
• Strong knowledge of mechanical design, 3D CAD modeling, GD&T, and tolerance analysis.
• Knowledge of materials, finishes, and fabrication processes.
• Experience with electromechanical assemblies, prototyping, and manufacturing.
• Experience in component testing and design verification.