Senior R&D Engineer

Luminate MedicalGalway, ConnachtOn-siteFull-timeSenior, 5–8 yearsListed 1 hour ago

Apply now

About this role

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 about new ideas.

- Open:  A proactive team player who seeks to 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:

- 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!