Mechanical Engineer

Responsibilities

The Mechanical Engineer will be responsible for optimizing and developing production processes and designing mechanical components for medical devices. This role will involve close collaboration with cross- functional teams to ensure that products meet the highest performance, safety, and regulatory compliance standards in a growing startup’s dynamic and innovative work environment.

• Create jigs, fixtures, and tooling to support assembly, testing and quality control.
• Design and develop new components and assemblies for new devices.
• Lead the implementation of engineering change orders (ECOs)
• Collaborate with manufacturing teams to troubleshoot and resolve production issues.
• Create and review detailed engineering drawings, specifications and documentation.
• Prototype and test new designs, analyse test data and iterate on designs.
• Participate in design reviews, risk assessments and continuous improvement initiatives.

Requirements

• Bachelor’s degree in mechanical engineering.
• +2 years of experience in mechanical engineering with a focus on medical devices.
• Proficiency in SolidWorks and engineering analysis tools.
• Strong understanding of material properties, manufacturing processes, and mechanical design principles.
• Experience with design for manufacturability (DFM), design for assembly (DFA) and design verification and validation.
• Strong understanding of Quality Management Systems (QMS).
• Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485).