Production Operations Manager - Aptyx

We are seeking a results-driven and highly skilled Operations Manager with extensive experience in production and operational management in a medical injection molding and medical assembly environment. This role will oversee production processes, ensuring efficient workflows, high-quality standards, and adherence to regulatory compliance. The ideal candidate is a strong leader with proven success in motivating teams, optimizing processes, achieving operational excellence, and fostering a culture of safety in a regulated, quality-driven setting.

Key Responsibilities

• Production Management:
  • Oversee day-to-day production operations for medical injection molding and assembly processes, ensuring productivity, quality, and efficiency targets are consistently met.
  • Manage shift supervisors and production engineers, with an oversight of 120 production personnel across three shifts running 24-6 to meet production goals and maintain operational continuity.
  • Develop and implement strategies to optimize workflows, reduce waste, and enhance production processes specific to medical manufacturing.
  • Coordinate with cross-functional teams to support seamless integration of new products and production changes within a regulated environment.
• Safety Leadership:
  • Serve as the leader of safety within the building, championing a culture of safety awareness and accountability.
  • Conduct monthly safety committee meetings to discuss safety performance, address concerns, and drive improvement initiatives.
  • Perform regular safety audits and inspections to ensure compliance with health, safety, and environmental regulations, taking corrective actions as needed.
  • Provide safety training and development programs for employees to ensure awareness of safety protocols and best practices.
  • Hold team members accountable to safety standards, recognizing adherence and addressing non-compliance, fostering a safety-focused culture throughout the organization.
• Leadership and Culture Development:
  • Lead, mentor, and develop a high-performing production team, fostering a culture of accountability, consistency, and continuous improvement.
  • Implement GEMBA walks to observe, engage, and gain insights into production processes directly on the floor, promoting transparency and proactive problem-solving.
  • Conduct regular production meetings to review key performance metrics, address issues, and align teams on objectives and improvement opportunities.
  • Promote a culture of process adherence, encouraging team members to actively participate in identifying areas for improvement and taking ownership of solutions.
• Collaboration and Communication:
  • Production Planning & Scheduling: Work closely with planners and schedulers to ensure production aligns with demand, achieving on-time delivery targets.
  • Customer Service: Collaborate with customer service to provide accurate, real-time information on production status, ensuring customers are informed and expectations are managed.
  • Purchasing: Partner with purchasing to ensure that all materials are on-site and on time for production, minimizing downtime and maintaining efficiency.
  • Tooling & Engineering: Collaborate with tooling and engineering teams on equipment, tooling maintenance, and any engineering changes, ensuring alignment with production needs and schedules.
  • Quality Assurance: Work closely with the quality team to ensure adherence to quality standards and regulatory requirements, collaborating on corrective actions and continuous improvement initiatives.
  • Human Resources: Partner with HR to align on labor needs, ensuring adequate staffing levels and proactively addressing employee relations, engagement, and retention within the production team.
• Operational Efficiency:
  • Analyze and monitor key performance indicators (KPIs) to identify areas for improvement and drive efficiency within medical molding and assembly operations.

• • Drive results by focusing on On-Time Delivery, sales revenue, productivity, and labor efficiency, ensuring all production activities contribute positively to the company's financial and operational goals.
  • Apply Lean and Six Sigma methodologies to streamline processes, reduce costs, and improve productivity in line with medical industry standards.

• Quality Assurance:
  • Collaborate with Quality Assurance to ensure adherence to medical device quality standards, including ISO 13485 and FDA regulations.
  • Implement corrective actions and continuous improvement initiatives to address and prevent quality issues.
  • Develop and maintain quality assurance protocols to reduce defects and ensure the highest level of patient safety and satisfaction.
• Budget and Resource Management:
  • Manage the production budget, ensuring cost-effective use of resources and materials for medical molding and assembly operations.
  • Coordinate with procurement to maintain a steady supply of medical-grade materials that meet stringent quality standards.
  • Forecast labor and equipment needs based on production demands and regulatory requirements.

Qualifications

• Bachelor's degree in operations management, Industrial Engineering, Business Administration, or a related field (Master's degree preferred).
• 5+ years of experience in a production management role within medical injection molding and assembly or a regulated manufacturing environment, with a proven track record of driving operational efficiency and leading teams to success.
• Strong knowledge of medical manufacturing standards, including ISO 13485 and FDA regulations.
• Proficiency in Lean Manufacturing, Six Sigma, and other process improvement methodologies.
• Excellent leadership, communication, and interpersonal skills with the ability to motivate and manage a diverse team.
• Experience managing budgets, production schedules, and quality assurance in a regulated environment.

Competencies

• Leadership: Inspires and motivates teams, leads by example, and fosters a collaborative work environment.
• Safety Focus: Actively promotes a safe work environment, adheres to safety protocols, and leads by example in fostering a culture of safety.
• Regulatory Knowledge: Thorough understanding of medical manufacturing standards, ensuring compliance with all quality and safety regulations.
• Analytical Skills: Uses data-driven insights to make informed decisions and drive continuous improvement.
• Problem Solving: Identifies issues quickly and implements effective solutions to maintain productivity.
• Attention to Detail: Ensures high accuracy and standards in all production tasks, maintaining compliance with regulatory and quality requirements.
• Adaptability: Thrives in a fast-paced, highly regulated environment, able to manage multiple priorities and adapt to changing demands.
• Process-Oriented: Embeds a culture of process improvement and adherence, using tools like GEMBA walks, production meetings, and employee engagement to reinforce a culture of continuous improvement and operational excellence.
• Collaboration: Proactively engages with internal teams (planning, customer service, purchasing, tooling/engineering, quality, HR, and safety) to align goals, resolve issues, and enhance overall operational efficiency and team engagement.