Senior NPI/Production Engineer
Ellume
Brisbane, Queensland, Australia
4d ago
source : JobLeads

Ellume is an Australian-based health technology company that develops and manufactures rapid and accurate digital diagnostics for medical practitioners and consumers.

We achieve this by integrating next-generation quantum dot diagnostics, reader technology and software. Our products are distinguished by their simplicity of design, ease of use, rapid time to result and connectivity.

About the role

Here at Ellume we are rapidly scaling up our innovative programs to deliver rapid digital diagnostic tests to patients around the globe.

These ground-breaking tests have the capability to accurately diagnose patient samples and immediately test for the presence of infectious diseases such as Influenza, Tuberculosis, RSV, Strep-throat, COVID-19 and many others.

We have a diverse and multicultural team of scientists, engineers, programmers and designers working together in order to bring these amazing products to market.

In order to deliver these projects on time, on budget and to the required specifications we need to recruit a Senior New Product Industrialisation (NPI) / Production Engineer.

This position will report to the NPI / Production Engineering Team Lead and will work closely with the engineering, product development and manufacturing team members.

In this role you will be responsible for the design for manufacture and assembly (DFMA), design transfer and process validation of a new product line.

The new product will be used for the diagnosis of COVID-19. There is a need to introduce a lean, reliable and high throughput manufacturing process that can produce millions of units per year.

This will be a challenging but highly rewarding role.

Benefits and perks

Medium-sized company undergoing significant expansion.

Dynamic culture

Part of a new collaborative team

Extensive new product pipeline

Close to public transport and cafes

Skills and experience

  • Tertiary qualification in Engineering (Mechanical / Electrical / Electronics / Mechatronics or equivalent).
  • Minimum 5 years of industry experience in NPI / Production Engineering or equivalent role that required the introduction of new processes in a fast paced and regulated environment.
  • Experience in working within a Quality Management System
  • Proven track record in design, innovation, validation, problem solving and process development.
  • Experience with creating documentation (WINs / SOPs), risk analysis (PFMEAs) and process validation activities (IQ / OQ / PQ).
  • Conducted and analysed structured experiments to characterise process performance and improve the design and / or process.
  • Experience in defining equipment requirements, equipment selection, conducting equipment testing (FAT / SAT) and equipment installation in a manufacturing environment.
  • Experience in supporting the setup of infrastructure required to conduct a manufacturing process, operator training and ongoing continuous improvement activities in Production.
  • Highly desirable :

  • Medical device industry experience and an understanding of GMP
  • Experience of LEAN manufacturing principals
  • Experience with key manufacturing processes (moulding, joining, small part assembly)
  • Experience of conducting facility validation
  • Demonstrated competence in allocation of work and in guiding / directing the work of others
  • The application form will include these questions :

  • Which of the following statements best describes your right to work in Australia?
  • Do you have experience working within a lean agile team?
  • How many years' experience do you have as a systems engineer?
  • What's your highest level of education?
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