Katalyst CRO is hiring: Manufacturing Engineer in Santa Clara

Overview

Manufacturing Engineer position requiring GMP, FDA, KPI, ISO Standards, Six Sigma, Lean Methodology, Risk management, Validation processes, and Manufacturing Automation experience. Responsibilities include leading manufacturing programs to drive process improvements, cost reductions, and quality enhancements, and collaborating with R&D, Quality, Supply Chain, and Manufacturing teams to ensure a seamless transition from product development to manufacturing.

Responsibilities

• 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.

Qualifications / 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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Engineering and Information Technology

Industries

• Retail, Appliances, Electrical, and Electronics Manufacturing, and Civil Engineering