Mechanical Design Engineer – Medical Devices

About the role

We are looking for a Mechanical Design Engineer to join LUMA Vision’s engineering team. You will help design and develop Class II medical imaging devices that support advanced cardiac procedures. The role involves turning concept ideas into detailed mechanical solutions that meet regulatory and manufacturing requirements.

Key responsibilities

• Design mechanical components and assemblies for Class II medical devices using Onshape.
• Develop subsystem and component requirements from system‑level inputs.
• Create detailed CAD models and engineering drawings.
• Support design verification and validation activities and document results.
• Review manufactured parts for compliance with drawings and specifications.
• Participate in design reviews and provide feedback on documentation.
• Generate and maintain design documentation for regulatory submissions.
• Investigate component and system issues, perform root‑cause analysis and propose design improvements.

Required profile

• Bachelor’s or Master’s degree in Mechanical Engineering or a related discipline.
• 5–9 years of experience in mechanical design and product development.
• Proven experience developing Class II medical devices.
• Strong understanding of engineering principles for complex components and assemblies.

Required skills

• Onshape CAD software.

What we offer

• Opportunity to work on innovative ultrasound cardiac imaging and navigation systems.
• Collaboration with multidisciplinary hardware, software, systems and quality engineers.
• Experience in a regulated medical‑device environment (FDA Design Controls, ISO 13485, ISO 14971).