Professional specialized in medical device engineering and safety & effectiveness evaluation and market clearance for high-risk medical devices. Experienced in QMS audits and regulatory requirements for medical device manufacturers. Specialties include design controls and manufacturing requirements for devices such as orthopedic implants, dental implants & components, aesthetic implants and fillers, general surgery implants & devices, cardiovascular devices, medical equipment & software, and surgical intruments and tools. Technical knowledge on medical device manufacturing and validations, including machining, injection molding, passivation, anodizing, finishing, laser marking, cleaning, sterilization, packaging, transportation, shelf-life, biocompatibility, risk management, performance & mechanical evaluation, MRI compatibility, personalized (patient-specific) products, additive manufacturing. Experience with ANVISA, FDA, CE-Mark and other regulations.Determined, dedicated and creative professional, with good logical thinking and good interpersonal skills. My purpose is to help clients and partners to develop safe and effective medical products and successfully bring them to market in a timely manner, maximizing the benefit to patients.