Deny B.

Mechanical Engineer | Medical Device R&D | Product Development | CAD Modeling | DFMEA | Prototyping | DFM/DFx 28+ years of hands-on engineering experience, including 17 years in the medical device industry, with additional product development experience across IT hardware, automotive, consumer electronics, and production equipment. Specialized in product development from concept through manufacturing, including concept generation, system architecture, CAD modeling, 2D manufacturing drawings, tolerance analysis, prototype development, developmental testing, DFMEA/failure analysis, detailed design documentation, verification & validation, and Design for Manufacturing/Assembly (DFM/DFA). Extensive experience supporting New Product Introduction (NPI), supplier engagement, costed BOM development, target-cost optimization, and mass-production transfer across manufacturing sites in Asia, North America, and Europe. Experienced in regulated medical device development environments supporting ISO 13485 and FDA design control processes, with hands-on leadership in cross-functional product development and system integration activities.