Mechanical Engineer

Role Summary

The Mechanical Engineer will play a key role in the design, development, and continuous improvement of mechanical systems and assemblies for Clarapath’s advanced SectionStar™ and TrimStar Pro™ platforms. This individual will contribute to all phases of the product development lifecycle, from concept generation and prototyping through verification, manufacturing, and field deployment. Working closely with electrical, software, manufacturing, quality, and customer-facing teams, the Mechanical Engineer will help develop robust, manufacturable solutions that meet performance, reliability, and regulatory requirements.

Responsibilities

• Create detailed 3D CAD models, drawings, and engineering documentation
• Perform engineering analyses, tolerance stack-ups, and design calculations to validate product performance
• Prototype, test, and troubleshoot mechanical designs to improve functionality, reliability, and manufacturability
• Collaborate with electrical and software engineers to integrate mechanical, electrical, and control systems
• Support product verification and validation activities, including test planning, execution, and documentation
• Work closely with manufacturing to transition designs into production and resolve production-related issues
• Participate in design reviews and implement design improvements based on feedback and testing results
• Ensure compliance with applicable quality system requirements, including ISO 13485 and FDA design control processes
• Assist in root cause investigations, corrective actions, and continuous improvement initiatives
• Maintain accurate engineering documentation, including BOMs, drawings, specifications, and change orders

Qualifications

• Bachelor's degree in Mechanical Engineering or related engineering discipline
• 2+ years of mechanical engineering experience; medical device, robotics, automation, or laboratory equipment experience preferred
• Proficiency with 3D CAD software (SolidWorks preferred)
• Experience creating manufacturing drawings and engineering documentation
• Understanding of mechanical design principles, materials selection, GD&T, and tolerance analysis
• Hands-on experience with prototyping, testing, and troubleshooting mechanical systems
• Strong analytical and problem-solving skills
• Excellent communication and collaboration skills
• Experience in medical devices, robotics, automation, or electromechanical systems, a plus
• Experience working within regulated environments and quality management systems, a plus
• Knowledge of ISO 13485, FDA design controls, or similar regulatory requirements, a plus