MidFull TimeEN
Exciting opportunity to join an Australian-based technology company on a global mission to revolutionise the field of chromatography and proteomics.
About Us
Melbourne-born and globally recognised, IonOpticks is the leader in specialised high-performance chromatography columns, trusted by scientists worldwide to transform the way proteomics and medical research are performed. Since 2017, our award-winning products have powered labs across leading universities and research institutes, enabling the most reliable and detailed analysis of data in the field.
Our team is deeply committed to enhancing chromatographic performance. We are currently looking for a like-minded, self-motivated, individual to join our growing team and be part of our success story as we scale the business.
Does this sound like you?
We are seeking an experienced NPI Engineer to join us in a new role to play a critical role in bridging Product Development with Production, ensuring the successful introduction of new products into manufacturing. They will be responsible for managing technical transfer, optimising processes, and ensuring products meet quality, regulatory, and performance standards, and will collaborate across teams to ensure smooth, efficient, and compliant product launches.
Key responsibilities
Lead the technical transfer of new products from Product Development into pilot and full-scale manufacturing.
Develop work packages as part of a staged development plan to successfully deliver projects within scope, with quality, and within allocated timeframes and budget.
Maintain engineering process discipline to achieve project deliverables, including but not limited to; manufacturing strategy, capability analysis, pFMEA, tooling selection, risk management, cost modelling, DFM, and process validation/qualification.
Develop, document, and optimise manufacturing processes, work instructions, and standard operating procedures (SOPs) for new products.
Support scale-up activities including pilot runs, process validation, and production trials.
Employ data driven tools and methodologies to implement structured and timely problem solving.
Conduct risk assessments and implement mitigation strategies to ensure compliant and efficient product launches.
Identify opportunities for process improvements and cost efficiencies during NPI activities.
Maintain clear project documentation, timelines, and status reports for stakeholders.
Ensure adherence to regulatory requirements (e.g., ISO standards, GMP) throughout the NPI process.
Develop and implement workflows to ensure best NPI engineering practises
Guide project teams through the selection of correct design / manufacturing concepts and fundamental technology to ensure successful project outcomes
Manage internal and external suppliers required to successfully complete a transfer to manufacturing
Provide technical training and guidance to production teams on new products and processes.
Key selection criteria
Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related field.
Proven experience (5+ years) in NPI, process engineering, or manufacturing within the life sciences or medical device industry.
Demonstrated ability to manage technical transfers from product development to production.
Intimate understanding of Design control, Validation and Verification and Risk Management processes under a Quality Management System
Strong understanding of GMP, ISO standards, and regulatory requirements in life sciences manufacturing.
Extensive and demonstrable experience with Design for Manufacture principles.
Excellent problem-solving, analytical, and project management skills.
Effective communication and collaboration skills, with strong experience working in cross-functional teams.
Ability to interpret technical drawings, process flow diagrams, and product specifications.
Knowledge of process improvement methodologies (e.g., Lean, Six Sigma).
Experience with project management tools and software.
Must be practically minded and hands-on
Why IonOpticks?
Our lean and rapidly growing team consists of high achievers, focused on developing new technologies in response to global market demand.
Our people are our priority and we are committed to supporting the ongoing personal and professional development of our team members.
We take pride in our culture that supports diversity and flexible working arrangements to ensure our team members continue to love doing what they do best.
We are a values-driven organisation where we thrive together, pursue excellence, continuously evolve, and create lasting impact.
How and where to apply
Let us know you’re keen to join our team by applying and sharing your CV and cover letter (don’t forget to tell us how you meet the key selection criteria in the cover letter!).
