Operations

• Support the development and execution of Conavi’s external manufacturing strategy to enable scale-up from pilot to full commercial production
• Contribute development of the long-term technical roadmap for external partners including capacity, automation, and cost-reduction priorities
• Lead all technical aspects of new product transfer from R&D to contract manufacturing ensuring robust process definitions and validations
• Establish and maintain comprehensive documentation packages (PFMEA, process flow, control plans, IQ/OQ/PQ)
• Oversee production readiness, yields, and technical support for high-mix, low-volume catheter builds and related subassemblies
• Partner with Contract Manufacturing teams to troubleshoot production issues and drive corrective actions
• Lead performance reviews with Contract Manufacturing partners covering quality, delivery, cost and technical capability metrics
• Lead initiatives to reduce cost of goods sold (COGS) through process optimization, material strategy, and supplier consolidation
• Ensure the deployment Lean and Six Sigma methodologies to improve throughput, reduce scrap, and enhance process stability at contract manufacturers
• Ensure all external operations are in compliance with FDA, ISO 13485 and MDSAP standards
• Collaborate with R&D to ensure smooth design transfer and lifecycle support
• Work closely with Quality to maintain robust CAPA, non-conformance, and change control processes at the Contract Manufacturers
• Partner with Supply Chain and Finance to align technical decisions with sourcing strategy and cost targets
• Attract, retain, and motivate technical operations staff

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