Senior R&D Engineer

Luminate Medical; Galway; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Pension plan

Company laptop

Headphones

Camera

Flexible working hours

Generous vacation policy

Job summary

Luminate Medical in Galway, Ireland seeks a Senior R&D Engineer to drive cancer care devices from concept to market. You will lead technical reviews, translate data into design direction, and push concepts toward manufacturing readiness using processes like injection moulding, vacuum forming, and 3D printing.

Collaboration with QA, RA, and manufacturing is essential to maintain quality and timelines. The role emphasizes mentorship, structured development, and delivering life-changing devices in

Qualifications

• 6+ years of R&D experience in medical devices.
• Experience with DHF documentation and design validation.
• Hands-on design for assembly/manufacturing including injection moulding and 3D printing.
• Ability to develop robust test methods and DV plans.
• Strong knowledge of regulatory requirements (FDA MDR ISO 13485 IEC 60601).
• Familiarity with ISO 13485 QMS and industry standards.
• Methodical, structured approach to product development.

Responsibilities

• Drive patient-focused cancer care products from idea to market.
• Lead technical reviews, interpret data, influence design direction.
• Develop concepts to manufacturing readiness using listed techniques.
• Lead tasks and projects with a structured approach.
• Evaluate materials and suppliers for manufacturability.
• Create and maintain design documentation and traceability.
• Collaborate with design assurance to perform FMEAs.
• Coordinate with manufacturing to ensure DFA.

Skills

R&D experience

DHF documentation

Design for manufacturing

Test method design

Regulatory knowledge

Quality management (ISO 13485)

Structured product development

Tools

Creo CAD

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 aSenior R&D Engineerto 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 comparable with multinational medical device companies, 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:

• Contributing to technical reviews, interpreting experimental data, and influencing design direction through 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.
• Leading 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 Leadership

• 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.
• Providing technical leadership and mentorship to junior team members, fostering growth and expertise within the team.

Personal Attributes – The Ideal Candidate Is:

• Creative: A creative problem solver who is enthusiastic aboutnew ideas.
• Open: A proactive team player whoseeksto 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 taskswith input from more senior colleaguesand ensureactions arecompleted on time.

Requirements – The Ideal Candidate Must Have:

• 6+ years of R&D experience, including 4+ years in the medical device sector, working on multiple product design and development projects.
• 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!