Mechanical Engineer – Medical Devices

Rapsys Technologies Pte Ltd.; Iowa; On-site; USD 70,000 - 100,000; Full time

Job summary

Rapsys Technologies Pte Ltd. in the United States (Iowa) 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 design components, develop subsystem requirements, create 3D CAD models with SolidWorks and Creo, perform GD&T and tolerance analysis, build prototypes, and collaborate with vendors and manufacturing teams to ensure successful

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

Mechanical design

3D CAD modeling

GD&T

Tolerance analysis

Electromechanical assemblies

Testing and verification

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.