ANDREA SALAZAR
Sydney,Australia
Summary
Biomedical Engineer with clinical background, experienced in supporting healthcare teams through surgical simulation, device validation, and anatomy-based training models. Skilled in sterile packaging testing (ASTM/ISO), regulatory compliance (ISO 13485, ISO 9001), and risk management. Proven ability to collaborate with clinicians in hospital environments, providing technical and procedural support. Committed to advancing surgical innovation, robotic technology, and improving patient outcomes through clinical excellence and technical expertise.
Overview
7
7
years of professional experience
1
1
Certification
Work History
New Process Introduction Engineer
Sabre Medical
Sydney, NSW
01.2024 - Current
- Led projects for new product introduction and process improvement in medical device sector.
- Owned manufacturing projects to develop medical kits, including Work Order Instructions, Component specifications and planning.
- Managed inventory control processes, ensuring accurate tracking of inventory items.
- Provided consulting on validation and verification strategies, achieving compliance with ISO 13485 and ISO 9001.
- Conducted sterile barrier testing, including Peel, Bubble, Dye, Burst, and Creep Tests.
- Executed functional device testing under accelerated aging and real-time conditions.
- Supervised testing projects to align with ASTM and ISO standards across packaging and sterility environments.
- Prepared technical protocols, SOPs, CAPAs, NCRs, ECOs, and test reports for regulatory submissions.
Biomedical Engineering Researcher - Lumbar Puncture Trainer
University of Wollongong – ISLHD/Wollongong Hospital
Wollongong, NSW
01.2023 - 01.2024
- Designed and manufactured a 3D lumbar model to replicate anatomical structures with precision for clinical applications.
- Developed an Enhanced Lumbar Puncture Trainer integrating sensor technology for real-time feedback.
- Collaborated with hospital clinicians in theatre-adjacent environments to validate anatomical accuracy and enhance procedural training outcomes.
- Gained practical experience in clinical workflows and surgical simulation.
Manager & Team Leader (Leadership Roles)
Metro St James & C.inc Pty Ltd
Sydney, NSW
01.2019 - 01.2024
- Managed day-to-day operations of restaurant, including scheduling, budgeting, and inventory control.
- Trained and mentored staff on best practices and company procedures.
- Built strong leadership, communication, and organizational skills.
Education
Bachelor of Biomedical Engineering -
University of Wollongong
Wollongong, NSW01.2024
Diploma in Business -
Lonsdale Institute
Sydney, NSW01.2020
Certificate IV in Leadership and Management -
Greenwich College
Sydney, NSW01.2019
Skills
TECHNICAL SKILLS
- Tools & Software: Fusion 360, Inventor, MATLAB
- Medical Device Testing & Validation: Peel, Bubble, Dye, Burst, Creep (ASTM/ISO) Functional & Aging Studies Sterile Barrier Validation
- Process & Quality: Risk analysis (FMEA), CAPA management, validation protocols, equipment qualification
- Training & Support: Development of SOPs, staff training, client support in validation strategies, communication with clinical teams
SOFT SKILLS
- Strong Communication & Clinical Collaboration
- Team Leadership & Training
- Problem-Solving & Adaptability
- Detail-Oriented & Resilient
Certification
- ISO 13485 - Certified for Medical Devices Quality Management Systems
- ISO 9001 - Quality Management Systems
- Internal Auditor (ISO standards)
- ISO Class 7 & 8 Cleanroom Trained
Timeline
New Process Introduction Engineer
Sabre Medical
01.2024 - Current
Biomedical Engineering Researcher - Lumbar Puncture Trainer
University of Wollongong – ISLHD/Wollongong Hospital
01.2023 - 01.2024
Manager & Team Leader (Leadership Roles)
Metro St James & C.inc Pty Ltd
01.2019 - 01.2024
Bachelor of Biomedical Engineering -
University of Wollongong
Diploma in Business -
Lonsdale Institute
Certificate IV in Leadership and Management -
Greenwich College
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