Operations Manager

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 #J-18808-Ljbffr