Production Manager

Production Manager
Onsite in Tempe, AZ ( must live local )
Full-Time

Position Summary
Our client is seeking an experienced and results-driven Production Manager to manage manufacturing operations within their medical device production facility. This individual will oversee all aspects of production, ensuring the efficient, compliant, and high-quality manufacturing of medical device components and products. The ideal candidate will possess a strong background in medical device manufacturing and hands-on experience managing dip molding operations, along with a proven track record of driving operational excellence, process improvements, and team development.
This role is responsible for achieving production goals while maintaining compliance with FDA regulations, ISO standards, quality requirements, and safety protocols.
Key Responsibilities

• Direct and oversee daily manufacturing operations, ensuring production targets, quality standards, and delivery schedules are consistently achieved.
• Manage all aspects of dip molding manufacturing processes, including process optimization, troubleshooting, capacity planning, and continuous improvement initiatives.
• Lead, coach, and develop production supervisors and manufacturing personnel to create a high-performance culture focused on quality, safety, and efficiency.
• Ensure compliance with FDA regulations, ISO 13485, GMP requirements, and all applicable medical device manufacturing standards.
• Collaborate closely with Engineering, Quality, Supply Chain, Maintenance, and Regulatory teams to support production objectives and product requirements.
• Monitor and analyze key performance indicators (KPIs), including throughput, yield, scrap rates, labor efficiency, downtime, and on-time delivery.
• Develop and implement process improvements that enhance productivity, reduce costs, and improve product quality.
• Drive root cause investigations and corrective actions for production issues, non-conformances, and customer complaints.
• Support new product introductions, process validations, and equipment qualifications.
• Ensure appropriate staffing levels, workforce planning, scheduling, and employee training programs.
• Manage departmental budgets and identify opportunities for cost reduction and operational efficiencies.
• Promote and maintain a safe working environment while ensuring compliance with all company and regulatory safety requirements.
• Participate in audits, inspections, and regulatory reviews as required.

Required Qualifications

• Bachelor's degree in Engineering, Manufacturing, Operations Management, or a related technical field.
• Minimum of 5 years of production management experience within a regulated medical device manufacturing environment.
• Required experience managing dip molding operations, including knowledge of materials, tooling, processing parameters, and quality controls associated with dip molding manufacturing.
• Strong understanding of FDA regulations, ISO 13485, GMP, and medical device quality systems.
• Demonstrated experience leading manufacturing teams in a high-volume production setting.
• Proven success implementing Lean Manufacturing, Six Sigma, or continuous improvement methodologies.
• Experience with production planning, scheduling, inventory control, and capacity management.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent leadership, communication, and organizational abilities.
• Proficiency with ERP/MRP systems and Microsoft Office applications.

Preferred Qualifications

• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with extrusion, catheter manufacturing, polymer processing, or other medical device component manufacturing technologies.
• Experience supporting process validation (IQ/OQ/PQ) and regulatory inspections.
• Knowledge of cleanroom manufacturing environments.

Key Competencies

• Production Leadership
• Medical Device Manufacturing Expertise
• Dip Molding Process Knowledge
• Continuous Improvement
• Quality Systems Compliance
• Team Development
• Strategic Planning
• Process Optimization
• Regulatory Compliance
• Operational Excellence

#INDQU