Job Description

Responsibilities

• Plan, coordinate, and control manufacturing operations for injection molding and automated assembly lines.
• Monitor and optimize equipment performance to ensure consistent quality and minimal downtime.
• Ensure full compliance with ISO 13485, FDA, GMP, and other applicable regulations.
• Collaborate with Quality Assurance on documentation, traceability, and validation.
• Lead root cause investigations and corrective actions for compliance or quality issues.
• Drive efficiency through process improvements using Lean, 5S, and Six Sigma methodologies.
• Analyze data to identify trends and implement continuous improvement initiatives.
• Supervise and mentor production staff, including technicians and supervisors.
• Promote a culture focused on safety, accountability, and ongoing learning.
• Optimize the use of labor, materials, and equipment to maximize production output.
• Coordinate with engineering and maintenance to ensure equipment reliability and rapid issue resolution.
• Enforce health, safety, and environmental standards, especially for automated and cleanroom environments.
• Lead risk assessments, safety meetings, and incident investigations.
• Prepare and deliver reports on production performance, compliance, and improvement plans to leadership.
• Maintain accurate records related to production, maintenance, downtime, and staff performance.

Qualifications

• Bachelor’s degree in an engineering discipline (or equivalent experience).
• 10+ years of experience in injection molding and automation, including 4+ years in a leadership role.
• Expertise in injection molding, automated systems (e.g., robotics, PLCs, vision systems), and cleanroom environments.
• Strong knowledge of ISO 13485, FDA, GMP, and other medical device regulations.
• Proficient in Lean Manufacturing, Six Sigma, or similar methodologies.
• Skilled in leadership, problem-solving, and communication.
• Proficiency with ERP/MRP systems, manufacturing analytics tools, and Microsoft Office.

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