Katalyst CRO is hiring: Manufacturing Engineer in Santa Clara

Join to apply for the Manufacturing Engineer role at Katalyst CRO We are seeking a highly skilled Manufacturing Engineer to join our team. The successful candidate will have experience in leading manufacturing programs, collaborating with cross-functional teams, and driving process improvements. Lead manufacturing programs to drive process improvements, cost reductions, and quality enhancements. Collaborate with R&D, Quality, Supply Chain, and Manufacturing teams to ensure seamless transition from product development to manufacturing. Develop comprehensive project plans, timelines, and budgets to meet business objectives. Identify risks and develop mitigation strategies to avoid delays and ensure compliance with regulatory standards. Monitor key performance indicators (KPIs) and generate reports to stakeholders. Ensure manufacturing processes adhere to Good Manufacturing Practices (GMP) and ISO standards. Drive continuous improvement initiatives within manufacturing operations. Facilitate communication and collaboration across departments to align project goals and milestones. Support validation, qualifications, and regulatory submissions related to manufacturing processes. Experience in leading manufacturing Automation programs. Exposure to AI/Gen AI technologies and implementation in the manufacturing site. Responsibilities Manufacturing Engineer, GMP, FDA, KPI, ISO Standards, Six Sigma, Lean Methodology, Risk management, Validation processes, Manufacturing Automation. Lead manufacturing programs to drive process improvements, cost reductions, and quality enhancements. Collaborate with R&D, Quality, Supply Chain, and Manufacturing teams to ensure seamless transition from product development to manufacturing. Develop comprehensive project plans, timelines, and budgets to meet business objectives. Identify risks and develop mitigation strategies to avoid delays and ensure compliance with regulatory standards. Monitor key performance indicators (KPIs) and generate reports to stakeholders. Ensure manufacturing processes adhere to Good Manufacturing Practices (GMP) and ISO standards. Drive continuous improvement initiatives within manufacturing operations. Facilitate communication and collaboration across departments to align project goals and milestones. Support validation, qualifications, and regulatory submissions related to manufacturing processes. Experience in leading manufacturing Automation programs. Exposure to AI/Gen AI technologies and implementation in the manufacturing site. Requirements Strong knowledge of GMP, FDA, ISO standards, and regulatory requirements. Demonstrated project management expertise, preferably PMP or equivalent certification. Excellent leadership, communication, and interpersonal skills. Ability to manage multiple projects in a fast-paced, dynamic environment. Proficiency with manufacturing/ERP software and MS Office Suite. Experience in the Medtech Industry. Cardiovascular device manufacturing experience preferred. Six Sigma, Lean Methodology, or other continuous improvement certifications. Knowledge of risk management and validation processes. Experience in leading manufacturing Automation programs. #J-18808-Ljbffr