Paul Shwed

About Paul Shwed

A proven technical leader delivering impactful results in the medical device, composites, pharmaceutical and petrochemical industries. Driven by high impact projects for the organization and the mentorship of young professionals through dedicated team leadership. Demonstrated successes in engineering, operations, process development, and capital strategy. Capital Strategy– Strategic asset and resource planning (STRAP), determining asset and facility strategies to meet operational growth projections. Experience defining and leading capital expansion, production transfer, and continuous improvement projects with a portfolio exceeding $200MM. Engineering Leadership - Successfully leads process and project engineering teams. Develops and manages sustaining engineering teams focusing on engineering talent development and operational improvements. Executes production transfer strategies for both product outsourcing and new manufacturing asset process development and start up. Team leader of up to 130 direct and indirect reports. Operations Team Leadership– Utilizes strong communication skills to engage stakeholders across the organization. Collaborates with the operations organization to exceed safety and performance metrics by creating strong partnerships and developing unified goals with both customers, operations teams and suppliers. Deep-dives with team into skills requirements and develops training programs and objectives to close gaps. Led teams of up to 100 operations associates as direct and non-direct reports. Quality Systems and Workplace Standards – Experience working within quality regulations: 21CFR820, ISO 13485, 21CFR210/211, AS 9100, and under regulatory guidance; OSHA, ANSI, NFPA, NEC, etc. Ensures compliance within the Engineering and Operations Departments while creating a safe work environment through local and corporate procedure development and adherence to company policies and Good Manufacturing Practices (cGMPs). Process Optimization – Six Sigma Black Belt and mentor who understands the importance of optimizing complex procedures in business. Continuously looks to shore up processes in engineering, maintenance, calibration, training, budgets, and contracts, reducing waste and improving efficiency across all areas. Optimization and stabilization of processes utilizing Six Sigma and Lean methodologies.

Experience

1. Director of Manufacturing Operations

   Scientia Vascular

   Sep 2022 — Present

   Director of Manufacturing Operations with responsibility for production, manufacturing engineering and new process development/transfer engineering. Charged with aggressively growing manufacturing through capital expansion, operational stabilization and improvement, and the development of robust production processes.

Education

• University of Utah - David Eccles School of Business

  MBA

  2012 — 2014

• Drexel University

  BS, Mechanical Engineering

Skills

• Six Sigma
• Lean Manufacturing
• Procurement
• Medical Devices
• Engineering Management
• Program Management
• Design for Manufacturing
• Engineering
• Project Engineering
• Materials
• Solidworks
• Project Management
• Process Improvement
• Continuous Improvement
• Iso Standards
• Manufacturing
• Iso
• Business Process Improvement
• Mechanical Engineering