Embedded software engineering director with strong technical skills in software architecture, design, development, testing, and maintenance of complex robotic system and Class I/II/III medical devices. Experienced throughout the entire product development lifecycle from conception to manufacturing, commercialization, and maintenance phases. Successfully designed and released embedded software for multiple products currently in the field. Managed US & offshore teams of highly skilled software managers, software engineers and control system engineers. Collaborated with marketing, clinical and cross-functional teams to timely release quality software with features to support company’s short and long-term business goals. Collaborated in the establishment of design control policies (SOP), procedures (SWI), and enforced best practices to ensure high-quality software.▪ 10 years as software engineering director▪ 13 years as hands-on software manager▪ 14 years as embedded software engineer▪ SDLC (Agile, Waterfall, Iterative, V-Shape)▪ Acquisition due diligence▪ Project management▪ Complaint investigation▪ Requirements, architectures, design ▪ Managed US & aboard software team▪ Root cause analysis▪ Closed-loop control system▪ FDA/MDD/MDR regulation ▪ IEC 62304 Medical Device SDLC▪ ISO 14971 Risk Management▪ ISO 13485 QMS▪ IEC 60601 Medical Electrical Equipment▪ FDA Guidelines and 510k process▪ Class I/II/III Medical Devices▪ FMEA, hazard analysis, risk assessment▪ Cybersecurity▪ MISRA C++ for Critical Systems▪ IEC 62304 gap analysis & remediation