Senior R&D Engineer

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!