Harba Solutions Inc.
Production Manager Job at Harba Solutions Inc. in Indianapolis
Harba Solutions Inc., Indianapolis, IN, US
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.