Aldo Rodriguez

• Led end-to-end project management for transferring innovative medical devices from development stage through feasibility studies to full-scale production release, ensuring compliance with FDA regulations and ISO 13485 quality management systems.
• Coordinated cross-functional teams including R&D, engineering, quality assurance, supply chain, and manufacturing to align on project milestones, resolving issues to achieve on-time delivery for 15+ product launches.
• Facilitated high-level communications with stakeholders and senior leadership, providing regular updates on project status, risks, and mitigation strategies, resulting in 100% stakeholder satisfaction and approval rates.
• Coordinate with local team for installation, operational, and process qualifications (IQ/OQ/PQ) for new production lines, validating equipment and processes to meet regulatory standards and optimize efficiency.
• Applied lean manufacturing principles to streamline operations, reducing waste by 20% and improving throughput in high-volume production environments.
• Managed capital expenditures and project budgets exceeding $3M annually, forecasting costs, tracking variances, and negotiating with vendors to stay under budget by an average of 15%.
• Oversaw risk assessments and feasibility studies, identifying potential bottlenecks early and implementing corrective actions to minimize delays.

• Supported new product transfers by developing and qualifying manufacturing processes for FDA-regulated medical devices, ensuring adherence to ISO 13485 protocols.
• Collaborated with cross-functional teams to implement production workflows, incorporating lean methodologies to enhance operational efficiency.
• Performed detailed engineering analyses and validations, including IQ/OQ/PQ, for equipment installations and process optimizations.
• Managed smaller-scale projects with budgets up to $300K, focusing on capital investments in automation and tooling to support mass production.
• Communicated technical progress and challenges to stakeholders, contributing to strategic decisions on product scalability.

• Responsible for sustaining activities. Scrap Reduction and process qualifications in current production product.
• Write and approve IQ, OQ, PQ protocols, reports and data. CA/PA investigation, action plan,
• implementation and effectiveness checks. Use of statistics and/or 6-sigma tools for process characterization, capability studies and improvement.

Lead and execute all phases of product qualification for mass production for different programs such as Honda, Toyota and Nissan