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.

• 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