Bhavesh Ronvelia, a lead consultant at MIS Fractional, offers over 20 years of experience in the medical device industry, specializing in operational efficiency and Lean Six-Sigma methodologies. At Confluent Medical Technology, he provided strategic leadership to multiple sites, optimizing processes, scaling production, and managing capital projects, while improving the balloon yield from 65% to almost 90% by eliminating common defects that occurs due to upstream process, resulted in savings of $150k year through a comprehensive quality assurance program compliant with FDA and ISO 13485 standards. He provides consulting services for Manufacturing Engineering, R&D, and Operations across the medical device, IVD, and pharmaceutical industries. 

• Operational Efficiency: Implementation of Lean Six-Sigma and continuous improvement initiatives to enhance production efficiency, reduce lead times, and improve capacity utilization, as demonstrated by a 25% efficiency increase at Confluent Medical Technology.
• Quality and Compliance: Development of quality assurance programs to ensure compliance with FDA and ISO 13485 standards, achieving up to a 30% reduction in quality issues and successful audit outcomes.
• Facility and CapEx Management: Oversight of facility operations, capital projects, and budget management, with experience managing multi-million-dollar budgets and delivering projects under budget at B. Bruan Medical.
• Process Scale-Up and Technology Transfer: Leadership in scaling production and transferring technologies, such as Nitinol stent production at MicroVention, resulting in cost savings of over $750K annually.
• Safety and Risk Management: Creation of comprehensive safety programs, reducing workplace incidents by 30%, and expertise in CAPA, NCMR, and root cause analysis to address customer complaints.