Senior Quality Engineer

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 technologies that help cancer centres deliver better, faster, and lower cost care for patients.

We are approaching key milestones in product development and commercialisation. As we scale, we are seeking a dynamic and hands-on Senior Quality Engineer (supporting Process Quality) to support our expanding manufacturing, facilities, and supply chain functions. This role is pivotal in ensuring quality, compliance, efficiency, and scalability as the company transitions from development to commercial stage.

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 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 novel technologies.
• 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, offering flexible working hours and a generous vacation policy.

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.
• Together with the R&D & Operations team, plan & support builds for R&D testing, product verification, clinical trials and commercial use of patient-facing medical devices.
• 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.
• Support day-to-day manufacturing, both in-house and with contract manufacturing partners (CMOs).
• Support the establishment of an assembly line within a class 8 cleanroom environment.
• Work cross-functionally (e.g. with clinical, R&D, manufacturing, finance) to ensure a high level of attention to detail and compliance with quality and business requirements.
• Train and mentor staff, as the company scales.
• Ensure compliance with relevant ISO and FDA regulatory requirements (e.g., ISO 13485, 21 CFR Part 820).

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. You can clearly communicate ideas and plans to people at all levels of the organisation.
• 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. Strong attention to detail and naturally pushes for excellence in all we do.
• 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: 6 years+ relevant engineering experience working within a regulated manufacturing environment.
  • Proven track record supporting internal operations teams and/or external manufacturing partners.
  • Strong knowledge of QMS, GMP, FDA and ISO13485 requirements.
  • Experience with root cause analysis, process improvement methodologies and non-conformance investigations.
  • Installation and validation of new equipment & processes
  • Experience in transferring products to production; line moves, transfer projects, NPI tech transfers.
  • Installing and validating new equipment / processes / test methods
• 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 is an advantage
• Experience: Experience working within a clean room manufacturing environment
  • Experience with injection moulded components or assemblies
  • Process validation experience
  • 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!