Mechanical Design Engineer

LUMA Vision; München; Hybrid; EUR 85.000 - 110.000; Vollzeit

Benefits dieser Stelle

Flexible hybrid working

Modern offices in Dublin and Munich

Employee share scheme

Zusammenfassung

LUMA Vision, a Munich and Dublin-based startup focused on advanced ultrasound imaging, seeks a Mechanical Design Engineer to design and verify mechanical components for Class II medical devices. You will develop CAD models, drawings, and documentation in a regulated environment, collaborating with hardware, software, and quality teams.

You will work to ISO 13485 and FDA Design Controls, contributing from concept through to manufacture while ensuring high-quality, compliant designs and robust

Qualifikationen

• Bachelor's or Master's degree in Mechanical Engineering or related field.
• 5-9 years' experience in mechanical design and product development.
• Experience developing Class II medical devices.
• Ability to produce detailed engineering drawings.

Aufgaben

• Design mechanical components and assemblies for Class II medical devices.
• Develop subsystem and component requirements based on system-level design inputs.
• Create detailed CAD models and engineering drawings using Onshape.
• Develop design verification and validation protocols, documenting results in formal technical reports.
• Participate in design reviews and provide constructive feedback on engineering documentation and designs.
• Support regulatory submissions by generating and maintaining design documentation.
• Investigate component and system issues, performing root cause analysis and recommending practical design improvements.
• Work in accordance with LUMA Vision's Quality Management System and established engineering procedures.

Kenntnisse

Multidisciplinary collaboration

Regulatory awareness

Problem solving

Documentation & reporting

Ausbildung

Bachelor's or Master's degree in Mechanical Engineering

Tools

Onshape

CAD software

Jobbeschreibung

Mechanical Design Engineer (m/w/d)

LUMA Vision is a start-up based in Dublin (Ireland) and Munich (Germany) developing innovative imaging technologies to advance healthcare and solve global unmet clinical needs. We apply rigorous engineering and design to create new hardware, software and data-science technologies towards clinical procedures. Our focus is on developing sophisticated ultrasound cardiac imaging and navigation systems that provide essential real-time visualization for advanced electrophysiology and structural heart procedures, leveraging diverse technologies to transform patient care.

To support the continued development of our platform, we are looking for a Mechanical Design Engineer to join our growing engineering team. This is an exciting opportunity to work on the design and development of innovative Class II medical devices, collaborating with multidisciplinary teams to bring cutting-edge technologies from concept through to clinical application.

Your role with us

As a Mechanical Design Engineer, you will contribute to the design, development and verification of mechanical components and sub-assemblies used within LUMA Vision's medical imaging platform. Working within a regulated medical device environment, you will develop innovative design solutions, create detailed CAD models and engineering drawings, and support verification and validation activities to ensure designs meet both technical and regulatory requirements. You will collaborate closely with hardware, software, systems and quality engineers, contributing to product development from concept through to manufacture while ensuring compliance with FDA Design Controls, ISO 13485 and ISO 14971.

What You Will Do

• Design mechanical components and assemblies for Class II medical devices.
• Develop subsystem and component requirements based on system-level design inputs.
• Create detailed CAD models and engineering drawings using Onshape.
• Develop practical design solutions that satisfy functional, manufacturing and regulatory requirements.
• Review manufactured components to ensure compliance with engineering drawings and specifications.
• Develop and execute design verification and validation protocols, documenting results in formal technical reports.
• Participate in design reviews and provide constructive feedback on engineering documentation and designs.
• Support regulatory submissions by generating and maintaining design documentation.
• Investigate component and system issues, performing root cause analysis and recommending practical design improvements.
• Work in accordance with LUMA Vision's Quality Management System and established engineering procedures.

What You Offer

• Bachelor's or Master's degree in Mechanical Engineering or a related discipline.
• 5-9 years' experience in mechanical design and product development.
• Proven experience developing Class II medical devices.
• Strong understanding of engineering principles relating to complex components and mechanical assemblies.
• Proficiency using a parametric CAD package, ideally Onshape.
• Ability to produce and interpret detailed engineering drawings.
• Experience with engineering revision control and configuration management.
• Hands-on experience supporting preclinical development activities.
• Excellent communication skills and the ability to work effectively within multidisciplinary teams.

Nice-to-have

• Experience working within FDA Design Controls.
• Knowledge of ISO 13485 and ISO 14971.
• Experience with mechatronic systems and electro-mechanical assemblies.
• Experience within the medical device or another regulated industry.
• Familiarity with project planning and product development processes.
• Experience using Finite Element Analysis (FEA) and Design of Experiments (DOE).
• Experience with microcontroller development or embedded systems.
• Practical workshop experience using engineering tools and equipment.

What You'll Bring

• A collaborative approach and enthusiasm for solving complex engineering challenges.
• Confidence communicating with colleagues across multiple disciplines and levels of the organisation.
• Ownership of technical work packages from concept through delivery.
• A proactive, hands-on attitude with a willingness to support laboratory activities and prototype assembly when required.
• Ability to work on-site in our Dublin office at least four days per week.

What we offer

• The opportunity to develop innovative medical technologies that directly improve patient care.
• Ownership of meaningful engineering work within a collaborative, multidisciplinary team.
• A growing international company with a strong focus on innovation, teamwork and professional development.
• Competitive salary with participation in the employee share scheme.
• Flexible hybrid working and modern offices in Dublin and Munich.
• The opportunity to shape the future of imaging in healthcare.

LUMA Vision is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, sex, disability, religion/belief, sexual orientation or age.