Sofia

Biomedical Engineer (MSc with Distinction) with 5 years of European medical device experience spanning R&D Quality Engineering, Design Engineering, and project leadership. Expert in Risk Management (ISO 14971), V&V strategies, and managing strict regulatory compliance (ISO 13485). Proven track record executing full-lifecycle product development (NPI), including innovative CAD design and manufacturing transfer, while collaborating directly with surgeons.

Demonstrated success managing technical files and driving international field operations, including on-site equipment installations and clinical staff training in high-pressure hospital environments. Seeking to leverage this unique combination of medical device quality, engineering precision and clinical-facing expertise in a Technical Project Delivery, Product Specialist, or Engineering Operations role. Open to relocation.

R&D Quality Engineer at Occuity (2025-03 – Present)

• Lead engineering and cross-functional teams through product milestones, coordinating technical documentation and system design reviews across multidisciplinary departments.
• Own the Technical File and Risk Management architecture (ISO 14971) for a complex medical device, managing FMEAs and hazard profiles throughout active R&D phases.
• Drive verification and validation (V&V) strategy, authoring and executing hardware/software test protocols to ensure system performance maps to clinical requirements.
• Support clinical trial execution, usability protocols, and external regulatory audits, translating technical risk and performance data for non-engineering stakeholders.

Quality Engineer at Adtec Healthcare Limited (2024-02 – 2025-03)

• Executed on-site product deployments and delivered technical training directly to clinical end-users and healthcare professionals in hospital environments.
• Led technical root-cause investigations at clinical centres, resolving field-performance issues under time pressure while liaising directly with hospital staff.
• Directed product validation programmes, including transport and shelf-life stress testing, and managed Technical Files/Design History Files supporting EU MDR compliance.

Product Design Engineer (NPI) at Corin Group (2021-09 – 2023-04)

• Collaborated directly with orthopaedic surgeons during cadaveric usability studies, translating clinical feedback into design improvements.
• Project leader for the development and manufacturing transfer of a new 3D-printed orthopaedic implant, coordinating cross-functional teams across R&D, Quality, Regulatory, Marketing, and Manufacturing.
• Presented technical decisions and project updates to cross-functional stakeholders at milestone and design reviews.
• Applied FEA (ANSYS) and used CAD (Siemens NX) to optimise implant and instrument designs ahead of verification testing.

Career Break (2023-05 – 2023-10)

• Immersed in independent travel across Southeast Asia to develop cultural adaptability, resourcefulness, and communication skills, followed by a strategic period focused on evaluating international MedTech opportunities from Portugal.

MSc in Biomedical Engineering – Newcastle University (2020-09 – 2021-09)

BSc in Biomedical Engineering & Biophysics – University of Lisbon (2017-09 – 2020-09)