Mechanical Design Engineer

About the company

LUMA Vision is a startup with offices in Dublin and Munich that builds advanced imaging technologies aimed at improving healthcare and addressing unmet clinical needs worldwide. The team combines engineering, design, software and data science to create new solutions for clinical use, with a strong emphasis on sophisticated ultrasound-based cardiac imaging and navigation for electrophysiology and structural heart procedures.

The company is expanding its engineering team and is hiring a Mechanical Design Engineer to help develop innovative Class II medical devices. This role offers the chance to work on cutting-edge products from early concept through clinical application in a multidisciplinary environment.

Role overview

In this position, you will help design, develop and verify mechanical parts and sub-assemblies used in LUMA Vision’s medical imaging platform. You will work in a regulated medical device setting, producing CAD models, engineering drawings and verification/validation documentation while making sure the work meets technical, quality and regulatory expectations.

You will partner with hardware, software, systems and quality colleagues throughout the product lifecycle, while following FDA Design Controls, ISO 13485 and ISO 14971 requirements.

Responsibilities

• Design mechanical parts and assemblies for Class II medical devices.
• Translate system-level inputs into detailed requirements for subsystems and components.
• Prepare precise CAD models and technical drawings in Onshape.
• Create practical design solutions that balance function, manufacturability and compliance needs.
• Inspect manufactured parts to confirm they match drawings and specifications.
• Plan and run design verification and validation activities, and document findings in formal reports.
• Take part in design reviews and give useful feedback on design files and engineering documentation.
• Assist with regulatory submissions by preparing and maintaining design records.
• Troubleshoot product or component issues, perform root cause analysis and propose design improvements.
• Follow the company’s Quality Management System and engineering procedures.

Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering or a closely related field.
• 5 to 9 years of experience in mechanical design and product development.
• Prior experience building Class II medical devices.
• Strong understanding of engineering principles for complex parts and assemblies.
• Hands-on ability with a parametric CAD tool, preferably Onshape.
• Capability to create and interpret detailed engineering drawings.
• Experience with revision control and configuration management.
• Practical involvement in pre-clinical development work.
• Strong communication skills and the ability to work effectively with cross-functional teams.
• Experience with FDA Design Controls is a plus.
• Knowledge of ISO 13485 and ISO 14971 is a plus.
• Exposure to mechatronic systems and electro-mechanical assemblies is a plus.
• Experience in medical devices or another regulated industry is a plus.
• Familiarity with project planning and product development processes is a plus.
• Experience with FEA and Design of Experiments is a plus.
• Experience with microcontroller development or embedded systems is a plus.
• Practical workshop experience using engineering tools and equipment is a plus.

Work style and expectations

• Collaborative mindset with enthusiasm for solving complex engineering problems.
• Comfortable communicating across functions and at different organisational levels.
• Able to own technical work packages from concept through delivery.
• Proactive, hands-on approach, including support for lab work and prototype assembly when needed.
• Must be able to work on-site in the Dublin office at least four days per week.

Perks and benefits

• Opportunity to build innovative medical technologies that improve patient care.
• Meaningful ownership of engineering work in a collaborative, multidisciplinary team.
• Work with a growing international company focused on innovation, teamwork and professional growth.
• Competitive salary with participation in an employee share scheme.
• Flexible hybrid working and modern offices in Dublin and Munich.
• Chance to help shape the future of healthcare imaging.

Equal opportunity

LUMA Vision is an equal opportunity employer and considers all qualified applicants without regard to ethnicity, sex, disability, religion or belief, sexual orientation or age.

Application note

The company invites interested candidates to submit their CV for consideration.