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Katalyst Healthcares and Life Sciences

Katalyst Healthcares and Life Sciences is hiring: Manufacturing Engineer in Sant

Katalyst Healthcares and Life Sciences, Santa Clara, CA, US, 95053

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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.
  • bility 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.