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Production Manager
Production ManagerHarba Solutions Inc. • Indianapolis, IN, United States
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Production Manager

Production Manager

Harba Solutions Inc. • Indianapolis, IN, United States
4 days ago
Job type
  • Full-time
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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    Production Manager • Indianapolis, IN, United States

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