Staff Medical Device Engineer

LUMA Vision Ltd.; Galway; On-site; EUR 80,000 - 110,000; Full time

Benefits offered by this job

Flexible working

International team

Learning environment

Job summary

LUMA Vision Ltd. in Galway is seeking a Staff Medical Device Engineer to advance cutting-edge imaging catheter platforms. You will design mechanical components, develop test methods, and support manufacturing transitions in a fast-paced startup environment.

Ideal candidates have 7+ years in medical devices, strong mechanical principles, catheter system knowledge, CAD proficiency, and excellent English communication. Travel up to 25% in Europe and beyond may be required.

Qualifications

• 7+ years of engineering experience in the Medical Device industry.
• Strong understanding of mechanical engineering theory and application.
• Knowledge of catheter-based mechanical systems for torque transmission.
• Experience with electro-mechanical catheter systems and rotary encoders.
• BE/BEng degree in Mechanical or Biomedical Engineering or similar.
• Proficient with 3-D CAD and 2D drawing preparation.
• Excellent communication skills in English.
• Hands-on multitasking and problem-solving with attention to detail.
• Ability to work in cross-functional teams across global operations.

Responsibilities

• Support RD/NPI activities at contract manufacturing site, on site 4 days a week.
• Design and develop mechanical components and assemblies for imaging catheter platforms.
• Develop test methods, fixtures, protocols and reports for evaluating product functionality.
• Generate design specifications based on engineering principles to meet functional requirements.
• Ensure design for manufacturability and cost considerations for manufacturing scalability.
• Root cause analysis and remediation of technical issues.
• Support transition to manufacturing using DOE/Window studies and LEAN tools.
• Identify and support vendors in component manufacturing.
• Contribute to cross-functional teams.
• Follow design control processes and generate regulated documentation.
• Understand quality policy and system requirements.

Skills

Medical device exp

Mechanical engineering

Catheter torque

Electro-mechanical catheters

Rotary encoders

3D CAD

Communication

Multitasking

Cross-functional teamwork

Education

BE/BEng in Mechanical or Biomedical Engineering

Tools

3D CAD

2D drawing

Job description

WHO ARE WE?

LUMA Vision is a start-up based in Dublin (Ireland) and Munich (Germany) developing cutting-edge innovative imaging technologies to significantly advance healthcare and solve truly global unmet clinical needs. With creativity, passion and focus, we apply our best-in-class engineering and design knowhow to create new hardware, software and data science technologies. To support our hardware development, we are looking for a Staff Medical Device Engineer to join our growing team based in Galway.

YOUR ROLE WILL BE

• Support RD/NPI activities at our contract manufacturing site, on site 4 days a week.
• Design and develop mechanical components, sub-assemblies and large assemblies for advanced imaging catheter platforms.
• Develop test methods, measurement systems, fixtures, protocols and reports for evaluating product functionality.
• Generate design specifications based on solid engineering principles to meet the functional requirements of any design.
• Ensure Design for Manufacturability, capacity planning and product cost impacts are considered in all decision-making such that designs can be scaled seamlessly into manufacturing at the required product cost.
• Root cause and remedy technical issues.
• Support a smooth transition of new products into manufacturing through development and implementation of manufacturing capabilities using structured Process Development DOEs/Window studies along with LEAN principles and tools including but not limited to Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis and Line Balancing
• Identify and support vendors in component manufacturing.
• Contribute to cross-functional teams.
• Follow design control processes while generating regulated documentation including Design Process Validations documentation.
• Understand the company's quality policy and quality system requirements applicable to tasks.
• Exhibit a great attitude as a team player who excels in a demanding start-up environment.

What You Offer

• 7+ years of engineering experience within the Medical Device industry.
• Strong understanding of mechanical engineering theory using first principles to inform designs and design decisions
• Knowledge of catheter-based mechanical systems for torque transmission such as HHS tubing/Laser cut hypotubes
• Experience with complex electro-mechanical catheter systems and connection methods Experience with rotary encoders
• BE/BEng degree in Mechanical/Biomedical Engineering or similar, post-graduate is a plus.
• Proficient with 3-D CAD and 2D drawing preparation.
• Excellent communication skills in English
• Hands-on multi-tasker with problem-solving skills and great attention to detail
• Ability to work in cross-functional teams that span global operations
• Strong work ethic with a team-oriented mindset
• The ability to travel up to 25% annually within Europe as well as internationally.

What We Offer

• Working on cutting edge imaging systems to the direct benefit of patients and improving healthcare.
• Becoming part of a dynamic, multi-national team of highly skilled individuals with a very strong focus on team culture and individual development.
• A learning environment where you can extend and build upon your skills and interests.
• Flexible working environment and an international culture as well as offices in Germany and Ireland.

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.