Senior R&D Engineer

Luminate; Galway; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Pension

Company laptop

Headphones

Camera

Flexible working hours

Generous vacation policy

Job summary

Luminate Medical is seeking a Senior R&D Engineer to lead design and development of patient-focused cancer care devices from concept to market readiness. You will drive multidisciplinary projects, work with external partners, and mentor junior engineers in a fast-paced startup environment.

You will contribute to risk assessments, design validation, and manufacturing integration, while maintaining high quality and regulatory compliance in a dynamic team setting.

Qualifications

• 6+ years of R&D experience, with 4+ years in the medical device sector.
• Hands-on experience in design for assembly/manufacturing, including injection moulding, vacuum casting, dip moulding, joining technologies, and rapid prototyping (3D printing).
• Proven ability to develop robust test methods for evaluating designs and carrying out Design Verification testing.
• Strong understanding of medical device regulatory requirements (FDA guidance, MDR, ISO 13485, IEC 60601).
• Familiarity with ISO 13485 and compliance with industry standards (FDA, MDR, IEC 60601).
• Methodical and structured approach to product development.

Responsibilities

• Drive product development from concept to manufacture with a structured, methodical approach.
• Contribute to technical reviews, interpret data, and influence design direction.
• Lead projects and manage suppliers to ensure timely delivery and manufacturability.
• Create and maintain design documentation, including DHF, risk assessments, and traceability matrices.
• Collaborate with RA/QA and manufacturing to ensure design for manufacturing and verification.

Skills

Creative

Open

Communicative

Self-Driven

Organised

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 a Senior R&D Engineer 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 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:

Drive product development from concept to manufacture by:

• 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!