Shape the Face of Cancer Treatment at Luminate Medical

Luminate Medical is on a mission to change the way we experience cancer care. We design and build products which revolutionise the patient experience of cancer treatment by eliminating the side effects of cancer treatment in a comfortable, portable and effective way. We’re currently building our flagship product Lily, a wearable electromechanical medical device to prevent the hair loss caused by chemotherapy, and Lilac, our next-in-portfolio electromechanical product to prevent peripheral nerve damage in chemotherapy patients.

We are looking for a Quality Engineer II (supporting Process Quality and Design Assurance). The level of seniority can be tailored to the expertise of the suitable candidate. Working closely with R&D, Clinical, Regulatory and Manufacturing Engineering colleagues you will provide quality expertise for our devices. You will also contribute to design for manufacturing and design for assembly considerations. Above all, you will need to enjoy working in a fast-paced 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 novel technology.
• We offer a highly competitive salary comparable with (or exceeding) multinational medical device companies, a flexible benefits package, alongside a company laptop, headphones and camera.
• Training and personal development is a key part of our culture. Comprehensive training will be provided. In addition, we will provide opportunities to develop and grow as an individual.
• We believe in quality of life in our products and for our people, and offer flexible working hours, along with generous vacation allowances.

What You Will Do:

• Ensure smooth transition of activities from design to manufacturing e.g. transition of dFMEA to pFMEA, transition of Design Specifications to Manufacturing Specifications, transition of Design Test Methods to Process Test Methods, etc.
• Support Design Verification and Design Validation testing and associated methods.
• Together with the R&D team, plan & support builds for R&D testing, product verification, clinical trials and commercial use of patient-facing medical devices.
• Lead the transfer of an assembly line for electromechanical medical device(s), with guidance from the Project Manager and Quality Director.
• Support validation of equipment and processes as required.
• Work with existing and future external manufacturing partners and suppliers.
• Continually look for opportunities to optimise processes.

Personal Attributes – The Ideal Candidate Is:

• Creative: A creative problem solver who is enthusiastic about new ideas.
• Open: 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: Strong written and verbal communication and collaboration skills. You are able to articulate ideas clearly and support ideas with evidence.
• Self-Driven: You have a sense of urgency in your work, are resourceful and independent, and thrive when taking responsibility for tasks. You engage in ongoing personal development.
• Organised: You can prioritise your list of tasks independently and ensure actions are completed on time.
• Teamwork: You enjoy working in a multidisciplinary team, all working towards a common goal.

Experience Requirements – The Ideal Candidate Must Have:

• Qualification: Engineering , scientific or technical degree (including ASQ CQE).
• Experience: 3 years+ engineering experience working within a manufacturing environment.
  • Within an ISO 13485 QMS or equivalent environment.
  • Optimising processes with a view to Design for Manufacturability (DFM).
  • Installing and validating new equipment / processes / test methods.
  • Problem solving & root cause investigations.
• Technical Skills:
  • Use of statistical tools.
  • Proficient in MS Excel & MS Word.
• Communication Skills: Comfortable and confident communicating with internal and external stakeholders.

Experience Advantages – It Would Be ‘Nice to Have’ \ Advantageous to Have:

• Qualification: Lead Auditor Certification.
• Experience: Experience working within a manufacturing environment.
  • Working with PCB & electrical components.
  • Experience with Electromechanical components or assemblies.
  • Process validation experience.
  • Processing polymeric/electromechanical components.
  • Previous experience working in a startup or SME environment.
  • Been responsible for line transfers.
  • Experience training or developing others.

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!