NATALIA SALGADO
Brisbane,Australia
Summary
Dynamic Biomedical Engineer with a comprehensive background in medical device design, risk management, and quality systems. Expertise in CAD design, process optimization, and regulatory compliance within the medical device industry. Proven ability to manage multiple projects simultaneously while maintaining attention to detail and delivering high-quality outcomes. Strong communicator adept at bridging the gap between design and QMS considerations, ensuring all decisions align with both functionality and compliance requirements.
Overview
7
7
years of professional experience
Work History
Biomedical Engineer
Laronix
Brisbane, Australia
09.2024 - Current
- Led CAD design for critical implantable medical device components, ensuring seamless transition from prototype to production-ready tooling.
- Created and maintained Process Failure Mode and Effects Analysis (PFMEA) documents to identify and mitigate risks in design and manufacturing.
- Supervised manufacturing operations, implementing QMS-driven strategies to meet regulatory standards and increase production capacity.
- Contributed to the development of Instructions for Use (IFUs) and other technical documentation, ensuring clarity and compliance.
- Coordinated with consultants and cross-functional teams to evaluate device performance and safety, implementing design changes to resolve issues.
- Developed supply chain strategies and managed bills of materials (BOMs) to scale production for international markets.
- Trained and mentored new team members, ensuring consistent adherence to quality and manufacturing protocols.
Manufacturing Technician
Laronix
Brisbane, Australia
04.2023 - 08.2024
- Part of the product development team performing standard CAD design and development work requiring application of standard engineering techniques, procedures and criteria to deliver functional devices
- Document design and development work including CAD designs, design specifications, design verification, and validation protocols
- Identify problems and provide user feedback for future product direction, improvement and enhancement
- Quality management and regulatory compliance assistance
- In charge of device kit production through 3D printing (Digital Light Processing)
- Assist with producing new design prototypes, and perform routine usability testing of the devices with patients
- Currently assisting with the design, prototyping, testing, and troubleshooting of new laryngectomy products from concept to completion
- Working with product team to create and present proof of concept models for all new devices in line with regulatory and quality requirements, product risk assessment and safety requirements
Design and Development Engineer
Ayúdame3D
Madrid, Spain
11.2019 - 03.2023
- CAD designer of arm prosthesis
- Incorporating the use of stereolithography and selective laser sintering to improve product quality
- Promoting technological advancement by incorporating the use of 3D scanners to create specialized detailed arm 3d printed prosthesis
- Designed and built innovative finger prostheses, expanding the variety of products for patients
- Design leader for anatomical specific patients by generating technical drawings, designing CAD prototypes, and testing 3d printed models to deliver functional arm and hand prosthesis
Regulatory Affairs Internship
Shire
Bogotá, Colombia
08.2017 - 02.2018
- Monitor tools of legislation in the regulatory framework of Colombia, Peru and Venezuela.
- Create an internal system for monitoring the active processes of product registrations.
- Develop interdepartmental relationships with the medical, commercial, networking, and global areas to validate the launch Adynovate in Colombia, first country in Latin America to market it.
Education
Graduate Diploma - Global Project Management
Torrens University Australia
AU08.2022
M.S. - 3D Printing and Advanced Additive Manufacturing
EDDM Engineering Education
ES06.2020
B.S. - Biomedical Engineering
University of Los Andes
CO06.2018
Skills
- Problem Solving
- Research and Analysis
- Medical Device Design & Manufacturing
- Process Failure Mode and Effects Analysis (PFMEA)
- Risk Management & Root Cause Analysis
- Design Control & Transition to QMS
- CAD Design (SolidWorks, Rhinoceros), 3D Printing, 3D Scanning, & DICOM
- Regulatory Compliance (ISO 13485, FDA Standards)
- Technical Writing (Instructions for Use, Reports, Test Protocols)
- Cross-Functional Collaboration & Training
References
- Nyan Khin
- Rae Adlington
Research
- Design of Fabrication and Evaluation of SIS Novel Regenerative Vascular Grafts for Hemodialysis Access, Collaboration in a Doctoral project from University of Los Andes, in which my work consisted of providing support to speed up research, achieving experimental learning in vascular grafts made of Porcine Intestinal Submucosa (SIS), and expanding knowledge in the area of regenerative and biocompatible biomaterials with the human body.
- Laparoscopic cholecystectomy design project, Project oriented towards the creation of a device for laparoscopic cholecystectomy treatment able to provide benefits such as the prevention of third degree wounds in the liver (due to the laparoscopic tweezers currently used), and the ease of device manipulation for the surgeon.
Languages
Spanish
Native/ Bilingual
English
Full Professional
French
Elementary
Timeline
Biomedical Engineer
Laronix
09.2024 - Current
Manufacturing Technician
Laronix
04.2023 - 08.2024
Design and Development Engineer
Ayúdame3D
11.2019 - 03.2023
Regulatory Affairs Internship
Shire
08.2017 - 02.2018
Graduate Diploma - Global Project Management
Torrens University Australia
M.S. - 3D Printing and Advanced Additive Manufacturing
EDDM Engineering Education
B.S. - Biomedical Engineering
University of Los Andes
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