Operations Manager - Injection Molding Medical Manufacturing

We are seeking a strategic, customer-focused Operations Leader to lead and optimize our manufacturing operations. This role is responsible for end-to-end plant execution, including Production, Manufacturing Engineering, Quality, and Maintenance.

As a key member of the Senior Leadership Team, this individual will contribute to business strategy, budgeting, and operational planning, while driving daily execution and performance.

The ideal candidate brings a strong foundation in engineering and quality, along with proven experience in regulated manufacturing environments. This leader will play a critical role in New Product Introduction (NPI), validation, and transfer of business, including the launch of new products and integration of equipment and processes from sister sites.

This individual is a highly collaborative and people-focused leader, capable of engaging with customers, aligning cross-functional teams, and building a strong, accountable culture.

Key Responsibilities

Strategic & Leadership Team Contribution

• Serve as a key member of the Senior Leadership Team, contributing to:
• Business strategy and long-term planning
• Annual operating plans and goal deployment
• Organizational design and capability building
• Provide leadership in budget development, cost management, and operational forecasting
• Demonstrate strong P&L awareness, aligning operational decisions with financial performance

Operational Leadership

• Lead plant operations across Safety, Quality, Delivery, Cost, and People (SQDCP)
• Drive execution through structured daily management systems and KPIs
• Build a culture of accountability, collaboration, and continuous improvement
• Ensure alignment between operational performance and customer expectations

Customer Engagement & Cross-Functional Collaboration

• Act as a key operations-facing leader for customers, supporting:
• Business reviews, technical discussions, and site visits
• Escalations and issue resolution
• Partner closely with Customer Service and Planning to:
• Align demand, capacity, and production schedules
• Communicate risks and ensure delivery commitments
• Collaborate with Program Managers, Engineering, and Quality to ensure seamless execution

Production & Manufacturing Execution

• Lead production through Production Managers and Shift Supervisors
• Ensure delivery of production targets with focus on efficiency, throughput, and schedule attainment
• Optimize performance in a high-volume, labor-intensive environment
• Drive improvements in OEE, capacity, and operational flow

Engineering, NPI & Validation

• Lead Manufacturing Engineering and provide strong technical leadership to operations
• Partner with NPI teams and Program Managers to:
• Support product development and transfer into manufacturing
• Ensure Design for Manufacturability (DFM)
• Execute and sustain process validation (IQ/OQ/PQ)
• Ensure successful launch of new products and processes, meeting quality, cost, and delivery expectations

Transfer of Business & Capacity Expansion

• Lead and support transfer of products, processes, and equipment from sister sites
• Oversee installation, qualification, and ramp-up of new machines and technologies
• Ensure smooth transitions with minimal disruption to customer delivery and quality performance
• Align resources, training, and process readiness to support capacity expansion

Quality & Regulatory Compliance

• Ensure compliance with ISO 13485 and applicable medical device regulations
• Partner with Quality to:
• Drive effective CAPA and root cause analysis
• Reduce defects, scrap, and customer complaints
• Maintain audit readiness and successful inspections
• Promote a proactive quality culture across operations

Maintenance & Equipment Reliability

• Oversee preventive and predictive maintenance programs
• Ensure high levels of equipment uptime and reliability
• Drive improvements in downtime reduction and asset utilization
• Support capital investment planning and execution

Continuous Improvement

• Lead Lean and Six Sigma initiatives across the plant
• Drive measurable improvements in:
• Throughput and cycle time
• Cost reduction
• Waste elimination
• Establish a culture of structured problem-solving and operational excellence

People Leadership & Culture

• Lead, coach, and develop teams including:
• Production leadership
• Manufacturing Engineering
• Maintenance leadership
• Build a people-first, high-performance culture focused on:
• Engagement and accountability
• Leadership development and succession planning
• Partner with HR to strengthen organizational capability and culture

Financial & Operational Performance

• Develop and manage plant budgets and cost performance
• Drive cost improvement initiatives and operational efficiency
• Utilize KPIs and data analytics to support business decision-making
• Align operational execution with financial goals and performance targets

Qualifications

Education

• Bachelor's degree in Engineering
• Advanced degree (MBA or MS) is a plus

Experience 10+ years of leadership experience in manufacturing operations

• Proven experience leading multi-functional teams (Production, Engineering, Quality, Maintenance)
• Strong experience with:
• New Product Introduction (NPI)
• Process validation (IQ/OQ/PQ)
• Transfer of business and equipment between sites
• Experience in medical device manufacturing strongly preferred
• Injection molding experience preferred

Technical & Leadership Skills

• Strong expertise in:
• Manufacturing Engineering and process development
• Validation methodologies
• Quality systems and regulatory compliance
• Deep understanding of ISO 13485
• Experience with Lean Manufacturing / Six Sigma
• Strong financial acumen with P&L awareness
• Excellent communication skills with the ability to engage customers and internal stakeholders

• Strategic & Financial Acumen
• Technical & Operational Leadership
• NPI & Product Launch Execution