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 manufacture products which aim to revolutionise the patient experience of cancer treatment by eliminating the side effects of cancer treatment in a comfortable, portable and effective way.

We are approaching key milestones in product development and commercialisation. As we scale, we are seeking a dynamic and hands-on Principal Engineer – Process Development to lead our manufacturing and process development of our latest devices. 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 novel technologies.
• We offer a highly competitive salary and benefits package.
• 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:

• Lead equipment and process validations (IQ/OQ/PQ).
• Support and oversee suppliers on process validations.
• Lead Test Method development and validations.
• Contribute to the generation of process documents, striving for a high standard to be created and maintained. Manage, mentor, and develop the Manufacturing Engineering team.
• Lead the design, implementation, and regulatory compliance of product labelling systems, including the use of BarTender (or equivalent) for label generation, establishing robust Unique Device Identification (UDI) standards, and managing the verification of UDI barcodes using appropriate scanning and verification tools.
• Lead line balancing, line re-design and process flow improvements through Lean Six Sigma.
• Design and develop jigs and fixtures to improve process yield, output capacity, and mistake-proofing.
• Identify areas where automation/semi-automation may be required to meet commercial scale output. Including equipment identification and design.
• Lead CAPAs related to manufacturing to ensure robust fixes are put in place.
• Support investigations on manufacturing-related complaints/returned devices from clinical trials.
• Be the SME for all activities related to manufacturing engineering.
• Collaborate with the R&D design team on optimising the design considering Design for Manufacture (DFM)principles.
• Initiate process controls and data collection to enable real-time feedback on yield.
• Plan and manage project timelines for manufacturing projects.
• Work with existing and future external manufacturing partners to ensure processes are meeting time and quality expectations.
• Continually look for opportunities to optimise the manufacturing processes through design and development.
• Use 3D CAD packages, e.g. SolidWorks and in-house prototyping tools, such as 3D printers, to design and create fixture concepts to aid assembly.
• Strive to meet and exceed expectations to deliver on quality, cost and timelines.
• Take responsibility for the delivery of project goals in a timely fashion by working closely with, guiding, and building relationships with external suppliers and manufacturing partners, managing their time effectively and maintaining the agreed timeline.

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 constructively and positively.
• Communicative: Strong written and verbal communication and collaboration skills. You can 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.
• Team Oriented: You enjoy working in a multidisciplinary team, all working towards a common goal.

Experience Requirements – The Ideal Candidate Must Have:

• Qualification: Engineering or relevant technical degree.

• Experience: 8+ years relevant experience working within a manufacturing environment (with a minimum 5 years in the medical device industry) as a Senior Manufacturing Engineer, Senior Process Development Engineer, Project Engineer, or equivalent. Experience must include:
• Working within an ISO13485 QMS or equivalent environment.
• Processing PCBs &/or electromechanical components
• Designing and configuring assembly spaces and optimising to improve throughput.
• Previous experience working in a startup or SME environment.
• Installing and validating new equipment & processes.
• Supporting supplier process validations, e.g. injection moulding, heat sealing, and bonding.
• Been responsible for line installations or line transfers
• Experience with Lean Six Sigma tools and techniques (Minimum Green Belt level)
• Proficiency in leading Root cause investigations through CAPA.
• Process analysis using statistical methods.
• People management
• Cleanroom manufacturing experience?

• Supplier Engagement: Comfortable and confident communicating and managing external suppliers.

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

• Engineering master's or further diploma in a relevant technical field.
• Processing polymeric materials within a cleanroom environment.
• Lean Six Sigma Black Belt

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!