Director of Business Planning and Operations

Position Summary

Lead, plan, and control all medical injection molding operations to ensure achievement of safety, quality, delivery, cost, and productivity objectives while maintaining compliance with medical device regulatory requirements and collective bargaining agreements within a unionized manufacturing environment.

Key Responsibilities

Ensure execution of daily, weekly, and monthly production plans.

Manage labor, equipment, materials, and resources to meet operational targets.

Monitor and drive key performance indicators (KPIs) related to Safety, Quality, Delivery, Cost, and Productivity.

Maximize Overall Equipment Efficiency (OEE), equipment utilization and manufacturing capacity.

Lead initiatives to reduce downtime (planned and unplanned) and improve operational efficiency.

Ensure compliance with applicable medical device regulations and standards, including ISO 13485, FDA requirements, GMP, and customer‑specific requirements.

Support internal, customers, and regulatory audits.

Ensure timely implementation of corrective and preventive actions (CAPA).

Promote a culture of quality, compliance, and continuous improvement.

Lead Lean Manufacturing initiatives.

Drive waste reduction, cost savings, and productivity improvement projects.

Support automation and process optimization efforts.

Utilize structured problem‑solving methodologies to eliminate recurring issues.

Lead, coach, and develop supervisors and operational leaders.

Establish performance objectives and conduct performance evaluations.

Identify training and development needs.

Build a high‑performance culture focused on accountability and employee engagement.

Maintain effective working relationships with union representatives.

Participate in conflict resolution, grievance investigations, and labor relations matters.

Support a positive labor environment while ensuring business objectives are achieved.

Promote a strong safety culture and ensure compliance with EHS regulations.

Lead investigations related to safety incidents and implement corrective actions.

Ensure adherence to environmental, health, and safety standards.

Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Industrial Engineering, Mechanical Engineering, or related field.
• Master’s degree preferred.
• 10+ years of manufacturing experience, preferably in medical device molding.
• 5+ years of leadership experience managing molding production operations.
• Experience in injection molding processes and cleanroom manufacturing environments.

Knowledge & Skills

Medical device manufacturing regulations (ISO 13485, FDA, GMP).

Injection molding processes and manufacturing technologies. Master molding preferred.

Lean Manufacturing and Six Sigma methodologies.

Production planning and capacity management.

Strong leadership, communication, and conflict‑resolution skills.

Financial acumen and budget management.

Advanced problem‑solving and decision‑making capabilities.

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