EA A

As a Medical Device Design Engineer, I was responsible for developing and improving medical devices from concept through production. My work involved collaborating with cross-functional teams—including clinicians, regulatory specialists, and manufacturing engineers—to ensure designs met clinical needs, safety standards, and regulatory requirements (such as ISO 13485 and FDA guidelines). I created 3D models and detailed engineering drawings using CAD software, conducted risk assessments (FMEA), and performed prototype testing and validation. I also supported verification and validation (V\&V) activities, participated in design reviews, and maintained design history files. My focus was on innovation, usability, and patient safety.