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 providers deliver better, faster, and lower cost care for patients.

We are approaching critical milestones in product development and commercialisation. As we scale, we are seeking a dynamic and hands-on Operations Manager to lead and optimise 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 and production 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 and benefits package.
• 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:

Manufacturing Operations

• Plan and manage day-to-day manufacturing operations, both in-house and with contract manufacturing partners (CMOs).
• Lead the establishment of an assembly line within a class 8 cleanroom environment.
• Build the core procedures and philosophy of the operations function for scaling.
• Create a structure for planning and managing production schedules, inventory systems and operations projects.
• Work cross-functionally (e.g. with clinical, R&D, manufacturing, finance, quality) to ensure a high level of attention to detail and compliance with quality and business requirements.
• Develop and maintain strong relationships with external manufacturers, ensuring performance to quality, cost, and delivery targets.
• Lead manufacturing readiness activities in support of clinical and commercial supply.
• Collaborate with Engineering, R&D and Quality product team from prototypes to design transfer, ensuring scale-up activities are robust and compliant.

Facilities Management

• In collaboration with the Facilities Lead, oversee the maintenance, safety, and regulatory compliance of company facilities.
• Manage facility modifications to meet evolving operational needs.
• Serve as point of contact for contractors and facility service providers.

Supply Chain & Procurement

• Lead end-to-end supply chain strategy, including procurement management, inventory management, logistics management, and supplier management.
• Develop a supply planning process to ensure uninterrupted supply of components and finished goods.
• Oversee supplier performance metrics and sourcing alternative suppliers/components as the business scales.
• Create and monitor supply chain performance metrics
  

Leadership & Compliance

• Hire, train and mentor operations staff, as the company scales.
• Manage operations team, including production, supply chain and manufacturing.
• Establish and monitor company KPIs and production dashboards.
• Ensure compliance with relevant ISO and FDA regulatory requirements (e.g., ISO 13485, 21 CFR Part 820).
• Drive continuous improvement initiatives across all operational areas.
• Contribute to strategic planning and budgeting for operations

Requirements

Personal Attributes – The Ideal Candidate Is:

• Leadership & Team-work: You enjoy working in a multidisciplinary team and can lead and motivate the team to pull together, all working towards a common goal.
• Flexible: You can operation in a fast-paced, hands on start-up environment, working flexibly across multiple projects and always finding a way to hit project goals on-time.
• 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: Excellent written and verbal communication and collaboration skills. You can 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 plan and co-ordinate team activities based priorities fed from company goals and functional KPIs.
  
• Experience Requirements – The Ideal Candidate Must Have:

• Qualification: Bachelor’s degree in Engineering, Life Sciences and/or higher qualification in Operations Management, Supply Chain or related field.
• Experience: Minimum 10 years’ relevant experience, with at least 5 years in operations within the medical device or similarly regulated industry.
  • Proven track record managing internal operations teams and/or external manufacturing partners.
  • Strong knowledge of QMS, GMP, FDA and ISO13485 requirements.
  • Experience with ERP systems, process improvement methodologies and non-conformance investigations.
  • Installation and validation of new equipment & processes
  • Root cause investigations and process improvement initiatives
  • Experience in transferring products to production; line moves, transfer projects, NPI tech transfers.
  • Experience managing budgets, forecasting and developing supply chain strategies.

Experience Advantages – It Would Be Advantageous to Have:

• Qualification: Engineering, operations, supply chain, PM or management master's or further diploma.
• Experience:
  • Experience managing a multi-disciplinary operations team.
  • Processing PCB & electrical components
  • Designing and configuring assembly spaces
  • Previous experience working in a startup or SME environment.
  • Experience with product launches and scaling operations from clinical to commercial.
  • Knowledge of ERP/MRP systems and supply chain analytics tools.
  • APICS CPIM or CSCP certification is an advantage.
  • Project management certification (e.g., PMP, Prince2) or Lean Six Sigma qualifications.

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!