Edward Settle Email & Phone Number

Melbourne, Victoria, Australia

East Melbourne, Victoria, Australia

At Neo-Bionica, I implemented a robust Quality Management System aligned with ISO 13485, leading to successful certification. I prepared and chaired management review meetings, delivering detailed quality reports and metrics that drove continuous improvement initiatives. I managed the documentation and analysis of customer complaints and nonconformances, raising CAPAs as needed. I also conducted staff training sessions to ensure adherence to policies, procedures, and standards. My role involved conducting risk analyses in line with ISO 14971, maintaining the equipment calibration and preventive maintenance schedule, and overseeing the upkeep of two ISO 14644 Class 7 cleanrooms. Additionally, I was responsible for facility management and maintaining strong relationships with facility suppliers.

Melbourne, Victoria, Australia

At Maxoniq, I played a key role in ensuring compliance and safety for three Class 2b medical devices, overseeing post-market surveillance and reporting adverse events and Device Incident Reports (DIR) to the TGA. I managed the ISO 13485 certified quality management system, addressing customer complaints, nonconformances, and initiating CAPAs. I conducted risk analyses in line with ISO 14971 and led both internal and supplier audits to uphold ISO 9001 and ISO 13485 quality standards. Additionally, I delivered impactful training sessions to new staff on our product range and regulatory requirements.

Melbourne, Victoria, Australia

I worked with Orthopaedic Surgeon (Mr. Ian Alkhafaji) and Associate Professor David Ackland (University of Melbourne) to research the biomechanics of the ligamentum teres. This involved performing the mechanical tests and analysing the results using python and excel.

Melbourne, Victoria, Australia

I assisted in the redesign of a Temporomandibular Joint (TMJ) prosthesis with consultation from clinicians and engineers. The design was functionally tested using a Finite Element Analysis Software. Where possible, ISO standards and ASTM standards where adhered to.

Knoxfield, Victoria, Australia

I worked in an engineering team to designed technical packaging solutions for the Defence Force while adhering to necessary standards. This also involved programming the CNC router and waterjet using CAD/CAM.

Master Of Engineering - Meng, Biomedical With Business

Bachelor Of Science - Bs, Human Structure And Function

Education record