Diego Menendez

• Led system design reviews and defined requirements for complex medical systems, including hardware and software, applying INCOSE systems engineering models and best practices to ensure performance, reliability, and regulatory compliance.
• Directed new product development and global implementation, collaborating with cross-functional teams and integrating feedback from clinical users.
• Managed design change analysis, maintaining system integrity and compliance with quality system regulations.
• Executed verification and validation (V&V), including formative and summative evaluations, protocol development, prototyping, fixture creation, and pre-clinical studies with porcine models.
• Applied risk management and quality assurance practices (FMEA, Hazard Analysis) across development and sustaining activities.
• Ensured compliance with medical device standards (IEC 60601, FDA guidance, ISO) and collaborated with external vendors and certification bodies, including TUV, Element, BSI, DEKRA, and Intertek.
• Leveraged Minitab and MATLAB for statistical analysis, test data evaluation, and performance optimization.

• Designed, configured, and maintained leak detection software and hardware.
• Commissioned international projects, both remotely and on-site at client locations.
• Conducted data analysis of hydraulic signals for system performance optimization.
• Implement regular testing, simulations, and validation protocols for leak detection systems.
• Contributed to the end-to-end project management process.

Internship: Design of a machine that assembles gas sampling lines in the medical devices industry, involving mechanical design, pneumatic systems and PLC programming.