Noah Wright

• Phone: +61 2 9123 4567
• Email: noah.wright@email.com
• Location: Sydney, Australia
• LinkedIn: noah-wright-bioeng

Summary

8 years of experience in biomedical engineering, driving the design, development, and validation of innovative medical devices from concept to market. Successfully led cross-functional teams in achieving regulatory compliance and enhancing product performance for critical healthcare applications.

Proficient in biomaterials selection, biomechanical analysis, and quality assurance protocols, consistently delivering solutions that improve patient outcomes and operational efficiency within the medical technology sector.

Expertise in ISO 13485 implementation and risk management frameworks for Class II and Class III medical devices, contributing to a 15% reduction in post-market surveillance issues at previous roles.

Experience

Senior Biomedical Engineer, MedTech Innovations Australia -- Sydney, Australia

Mar 2020 – present

• Led the R&D team for a novel implantable neurostimulator, achieving TGA approval within 24 months and securing a $5M investment round.

• Developed and validated biocompatibility testing protocols for new polymer-based medical devices, ensuring compliance with ISO 10993 standards and reducing test cycles by 20%.

• Managed the design control process for three Class II medical devices, coordinating with manufacturing, regulatory affairs, and quality assurance to ensure successful product launches.

• Implemented advanced biomechanical simulation techniques (FEA) to optimize device design, resulting in a 10% reduction in material usage and improved device longevity.

Biomedical Engineer, Biocare Solutions Pty Ltd -- Melbourne, Australia

July 2016 – Feb 2020

• Contributed to the design and testing of a new generation of orthopaedic implants, participating in cadaveric studies and fatigue testing to validate performance.

• Authored technical documentation for regulatory submissions (TGA, FDA 510(k)), ensuring adherence to all relevant standards and guidelines.

• Assisted in the development of a cardiovascular stent, conducting material characterization and mechanical property analysis to select optimal alloys.

• Collaborated with clinical teams to gather user feedback and translate requirements into engineering specifications for medical device enhancements.

Education

University of New South Wales, Master of Engineering (MEng) in Biomedical Engineering -- Sydney, Australia

Feb 2015 – June 2016

University of Sydney, Bachelor of Engineering (BE Hons) in Mechanical Engineering with Biomedical Specialization -- Sydney, Australia

Feb 2011 – Nov 2014

Skills

Medical Device Development: Design Control, Risk Management (ISO 14971), Regulatory Affairs (TGA, FDA), QMS (ISO 13485), Prototyping, Verification & Validation

Biomaterials & Biomechanics: Biocompatibility (ISO 10993), Material Science, Finite Element Analysis (FEA), SolidWorks, ANSYS, Mechanical Testing

Laboratory & Testing: In Vitro Testing, In Vivo Studies, Statistical Analysis, Data Interpretation, Good Laboratory Practice (GLP)

Project Management: Cross-functional Team Leadership, Agile Methodologies, Project Planning, Stakeholder Management, Technical Documentation

Software & Tools: MATLAB, Python (Data Analysis), Minitab, JMP (Statistical Software), Microsoft Office Suite