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CAREER SUMMARY

Senior Biomedical Engineer with 7 years of experience in the design, development, validation and lifecycle management of biomedical equipment, medical devices and healthcare technologies. Experienced in medical device engineering, product development, verification and validation, risk management, technical documentation and regulatory compliance. Strong background translating clinical and user requirements into practical engineering solutions while considering safety, reliability, usability and manufacturability. Experienced in collaborating with clinicians, researchers, engineers, manufacturers, suppliers and regulatory stakeholders throughout the product development lifecycle. Strong understanding of quality management systems, medical device standards and risk-based engineering practices, with a focus on developing safe, reliable and effective healthcare technologies.

EDUCATION

The University of Western Australia, Perth WA
Bachelor of Engineering — Biomedical Engineering, February 2014 – December 2017

EXPERIENCE

Medical Technology Solutions Australia, Perth WA — Senior Biomedical Engineer, January 2022 – Current

Lead biomedical engineering activities across the design, development, validation and lifecycle management of medical devices and healthcare technologies.
Work closely with clinicians, healthcare professionals, product managers and multidisciplinary engineering teams to understand clinical needs and translate them into engineering requirements.
Develop and evaluate medical device concepts, engineering designs, prototypes and technical solutions based on user, clinical and product requirements.
Perform engineering analysis, design verification and technical assessments to evaluate device performance, safety and reliability.
Develop engineering specifications, technical drawings, design documentation, test plans, verification reports and product technical files.
Lead verification and validation activities, including test planning, execution, data analysis and documentation of results.
Apply risk management principles to identify potential hazards, assess engineering risks and develop appropriate risk controls and mitigation strategies.
Support product development activities from early concept and prototyping through design transfer, manufacturing and post-market support.
Work closely with manufacturing partners and suppliers to review technical specifications, resolve engineering issues and improve product quality.
Investigate product failures, complaints and technical issues, conducting root-cause analysis and implementing corrective and preventive actions.
Maintain design history, configuration management and engineering change documentation throughout the product lifecycle.
Support regulatory and quality activities by preparing technical evidence and documentation required for compliance and product submissions.
Mentor junior biomedical engineers and provide technical guidance on design, testing, risk management and engineering documentation.
Present technical findings, project progress and engineering recommendations to senior management, clinical stakeholders and cross-functional teams.

Healthcare Engineering Services, Perth WA — Biomedical Engineer, January 2019 – December 2021

Supported the design, evaluation, installation and maintenance of biomedical equipment and medical technology across healthcare environments.
Worked with clinical teams to understand equipment requirements, operational challenges and opportunities for technology improvement.
Conducted equipment inspections, performance testing and technical assessments to ensure biomedical equipment operated safely and reliably.
Assisted with the development and modification of medical device components, assemblies and engineering systems.
Prepared technical specifications, engineering drawings, equipment documentation and maintenance procedures.
Supported verification and validation testing for new and modified medical equipment and device components.
Investigated equipment faults and technical issues, identifying root causes and implementing appropriate engineering solutions.
Coordinated with suppliers, manufacturers and service providers to resolve technical issues and manage equipment-related projects.
Assisted with procurement activities by reviewing technical specifications, evaluating equipment options and supporting supplier assessments.
Maintained accurate equipment records, maintenance documentation, test results and engineering reports.
Participated in risk assessments, safety reviews and quality improvement activities related to biomedical equipment.
Supported compliance with relevant medical device standards, healthcare requirements and organisational procedures.
Contributed to continuous improvement initiatives focused on equipment reliability, patient safety and operational efficiency.
TECHNICAL SKILLS

Biomedical Engineering: Medical devices, biomedical equipment, healthcare technology, medical instrumentation, device development, clinical engineering, equipment lifecycle management

Medical Device Design: Product development, prototyping, mechanical design, electronics integration, design requirements, engineering specifications, design reviews, design transfer

Verification & Validation: Test planning, verification testing, validation testing, performance testing, test protocols, test reports, data analysis, equipment qualification

Risk & Compliance: Risk management, hazard analysis, FMEA, CAPA, change control, quality management systems, medical device compliance, technical documentation

Engineering & Analysis: Mechanical systems, electronics, sensors, instrumentation, engineering calculations, reliability analysis, root-cause analysis, failure investigation

Software & Tools: SolidWorks, AutoCAD, MATLAB, Python, LabVIEW, Microsoft Excel, statistical and engineering analysis tools

Quality & Regulatory: ISO 13485, ISO 14971, IEC 60601, quality systems, regulatory documentation, design controls, configuration management

Healthcare Systems: Biomedical equipment management, clinical engineering, equipment commissioning, preventive maintenance, technical assessment, healthcare risk management

Professional Skills: Technical leadership, problem-solving, analytical thinking, clinical stakeholder communication, project management, supplier management, mentoring and technical documentation

Education

2014-02 to 2017-12
Bachelor of Engineering — Biomedical Engineering
The University of Western Australia, Perth WA

Skills

Biomedical Engineering | Medical Device Engineering | Medical Devices | Clinical Engineering | Healthcare Technology | Medical Instrumentation | Product Development | Medical Device Design | Prototyping | Verification & Validation | Risk Management | FMEA | ISO 13485 | ISO 14971 | IEC 60601 | Quality Management Systems | Design Controls | Regulatory Compliance | Technical Documentation | Design Verification | Equipment Testing | Biomedical Equipment | Equipment Commissioning | Preventive Maintenance | Reliability Engineering | Root-Cause Analysis | CAPA | Change Control | SolidWorks | AutoCAD | MATLAB | Python | LabVIEW | Project Management | Supplier Management | Technical Leadership | Stakeholder Management

Occupation: Senior Biomedical Engineer

Experience: 7 years

Location: Western Australia, Australia

Skills: Medical Devices, Quality, Research

Experience: 7 years

Daily rate: AUD 550

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