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Senior R&D Engineer

Job Description - 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!

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