R&D Engineer Ii

Luminate Medical; Galway; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Pension

Company laptop

Headphones and camera

Flexible working hours

Generous vacation policy

Job summary

Luminate Medical in Ireland (Galway) is seeking a R&D Engineer II to advance our life-changing device from proof of concept to a market-ready product. You will be a key contributor in a fast-moving team, driving projects with a focus on patient impact and delivery against timelines.

You will work with the R&D Lead, Project Manager, and RA/QA to ensure quality standards, manage suppliers, and push the device toward manufacturing readiness using techniques like 3D printing, vacuum forming, and

Qualifications

• 2-5 years of R&D experience in a medical device environment.
• Minimum Level 8 degree in Engineering (NFQ Ireland).
• Expertise with Design History File (DHF) documentation and related design verification methods.
• Hands-on design for assembly/manufacturing and rapid prototyping (3D printing).
• Knowledge of medical device regulatory requirements (FDA, MDR, ISO 13485, IEC 60601).

Responsibilities

• Drive product development from concept to manufacture with structured project ownership.
• Develop concepts from prototypes to manufacturing readiness (vacuum forming, injection moulding, dip moulding, heat sealing, laser cutting, 3D printing).
• Create and maintain design documentation and traceability matrices.
• Collaborate with QA/RA and manufacturing teams to ensure quality and timeliness.
• Evaluate materials, components and suppliers for manufacturability.

Skills

R&D Experience

Medical device knowledge

Design for manufacturing

Regulatory understanding

Creative problem-solving

Education

Engineering (NFQ Level 8)

Tools

CREO CAD

DHF documentation

Job description

Shape the Future of Cancer Care at Luminate Medical

At Luminate our mission is to make cancer care more human.

We’re looking for a R&D Engineer II to be a leading contributor to our latest device in our product range, bringing the device from proof of concept phase through to a market-ready product. This is an exciting opportunity to be part of a multi-award-winning team and play a decisive part in the development and production of life changing devices. Above all, you will need to enjoy working in a fast-moving team environment, be passionate about working with people, and thrive in taking responsibility for delivering projects on-time to make a real-world patient impact.

Working at Luminate Medical

• This is a key early hire at a rapidly growing company. You will have an opportunity to shape the development of multiple high-impact patient-facing products and gain first-hand insights into the growth of a start-up.
• We offer a highly competitive salary, a flexible benefits package (including health insurance and pension), alongside a company laptop, headphones and camera.
• We believe in quality of life in our products and for our people, and offer flexible working hours, and a generous vacation policy.

What You Will Do:

Become a technical contributor within the R&D group to drive patient-focused cancer care products from idea to manufacture, including:

Drive product development from concept to manufacture by:

• Contributing to technical reviews, interpreting experimental data, and brainstorming sessions.
• Developing concepts from early prototypes to manufacturing readiness using techniques such as vacuum forming, injection moulding, dip moulding, heat sealing, laser cutting, and 3D printing.
• Owning tasks and projects with a structured, methodical approach to product development.
• Evaluating and sourcing materials, components, and suppliers to ensure optimal design and manufacturability.
• Communicating design decisions effectively, interpreting research literature and test results to refine and improve designs.
• Creating and maintaining design documentation, including drawings, specifications, technical reports, user needs, product requirements, and traceability matrices.
• Collaborating with design assurance to conduct risk assessments through FMEAs.
• Working with manufacturing engineers to ensure DFA throughout design.

Testing, Analysis, and Development of Novel Medical Devices

• Building prototypes to validate design concepts.
• Developing and implementing test methods to ensure safety and effectiveness.
• Predicting design outcomes through mathematical modelling, digital analysis, and experimental validation.
• Utilising user testing groups to gather real-world insights and iterate on designs.
• Working with the V&V engineer to validate test methods for design verification.

Project Execution and Ownership

• Taking ownership of critical and complex technical tasks to drive project success.
• Collaborating with the R&D Lead, Project Manager, and RA/QA teams to maintain timelines and uphold quality standards.
• Managing external suppliers and manufacturing partners, ensuring timely delivery and alignment with project goals.

Personal Attributes – The Ideal Candidate Is:

• Creative: A creative problem solver who is enthusiastic aboutnew ideas.
• Open: A proactive team player whose eksto help develop your teammates. You are willing to adopt, engage with and shape company culture in a positive manner.You can give and receive candid feedback in a constructive and positive manner.
• Communicative: Proficient in written and verbal communication and collaboration skills. You are able to share ideas and support exploration of other ideas.
• Self-Driven: You have a sense of urgency in your work and thrive when taking responsibility for tasks.
• Organised: You can prioritise your list of tasks with input from more senior colleagues and ensure actions are completed on time.

Requirements – The Ideal Candidate Must Have:

• 2-5 years of R&D experience, preferably in a medical device environment working on multiple product design and development projects.
• Minimum Level 8 degree in Engineering, as per the National Framework of Qualifications (NFQ) Ireland, is required.
• Expertise in Design History File (DHF) documentation, including Design Inputs, Test Method Design & Validation, and Design Verification Plans.
• Hands-on experience in design for assembly/manufacturing, with knowledge of injection moulding, vacuum casting, dip moulding, joining technologies, and rapid prototyping (3D printing).
• Proven ability to develop robust test methods for evaluating designs, predicting outcomes, and guiding iteration and carrying out Design Verification testing.
• Strong understanding of medical device regulatory requirements, including FDA guidance, MDR, ISO 13485, and IEC 60601.
• Familiarity with Quality Management Systems (ISO 13485) and compliance with industry standards, in particular FDA guidance, MDR guidance, ISO 13485 and IEC 60601.
• Methodical and structured approach to product development.

Experience Advantages – It Would Be Advantageous to Have:

• Experience working with wearable products that involve textiles.
• CREO CAD experience.
• Experience in design for sterilisation.
• Experience testing autoinjectors and/or vascular access devices.
• Prior experience designing and executing usability studies and incorporating human factors considerations into the product design.
• Experience with design for electromechanical and pneumatic devices.

Don’t have all of these requirements?

Some people are less likely to apply for a role unless they are 100% qualified. Your experience, skills and passion will set you apart – tell us what you have learned and achieved, whether personal or work-related! With the right mindset, many of the skills above can be learned on the job. If this role excites you, don’t let the description hold you back!