Elena Hebden Email & Phone Number

Sydney, Nsw, Au

Sydney, Nsw, Au

Sydney, New South Wales, Australia

- Engineering lead for various production investigations, conducting root cause analysis, utilising problem-solving tools such as DMAIC, is/is not, fishbone analysis and 5 Whys with a cross functional team.- Optimise manufacturing product yield by completing DOE study through analysis of characterisation results.- Utilising Minitab to statistically analyse current process variability and presenting project solutions to the Leadership team & Manufacturing Monthly Forum.- Lead and support NCR, CAPA and quality investigations; Ensuring adherence and compliance with Quality Systems and relevant regulatory bodies, such as ISO 13485, to maintain high quality and safety standards.- Continuation of responsibilities carried out as an engineering intern, as listed below

- Leading introduction of new equipment & equipment upgrades, and conducting IQ/OQ/PQ Validation - Core engineer for the introduction of a new Centerless grinder to reduce grinding cycle time by 95%.- Design of various poke-yoke tools to assist operators with difficult assembly steps, from initial design prototyping to validation and implementation into production.- Using Change Management Process to remediate work instructions, involving close collaboration with cross-functional teams, effectively managing stakeholders in R&D, PD, Quality, Regulatory and Production. -Integrating voice of the customer-driven improvements for work instructions and production equipment - Owner of monthly failure mode analysis across all implantable products manufactured on site. This data is presented to the Saluda Snr Leadership Team.- Asset management including conducting equipment maintenance (preventative, unscheduled, scheduled) to reduce operational downtime

Balmain

- Manage a high standard of professional communication and customer service to patients in person and via phone - Organise and manage patient files and correspondence- Process payments and Medicare claims

Bachelor Of Engineering (Honours) Bachelor Of Medical Science, Mechatronic Engineering And Medical Science

Education record