Operations Manager - Medical Manufacturing - Injection Molding

Job Description

Job Description

We are seeking a strategic, technically strong, and results-driven Operations Manager to lead and scale manufacturing operations within our Injection Molding Center of Excellence focused primarily on medical device manufacturing.

As a key member of the Senior Leadership Team (SLT), this individual will be responsible for driving operational excellence, organizational capability, customer satisfaction, and profitable business growth while leading Production, Planning, Purchasing, Warehouse,

Shipping/Receiving,

and Maintenance functions.

This role requires a leader who can successfully bridge operations and engineering, translating technical manufacturing capabilities into operational execution and business results. The Director of Operations will partner closely with Engineering, Quality, Tooling, Program Management, Customer Service, Finance, and Human Resources to ensure the organization delivers world-class performance in safety, quality, delivery, cost, and customer satisfaction.

The ideal candidate possesses deep manufacturing expertise, strong technical aptitude, proven leadership experience, and the ability to build scalable systems and teams capable of supporting significant business growth, automation, and operational complexity.

Key Responsibilities Strategic Leadership & Business Performance Serve as a key member of the Senior Leadership Team, contributing to overall business strategy, annual operating plans, long-term growth initiatives, and organizational development. Partner closely with the General Manager to establish operational priorities aligned with strategic objectives and customer commitments. Drive operational scalability to support business growth, new product introductions, automation initiatives, and increased manufacturing capacity. Support capital planning, investment decisions, and operational strategies that improve profitability and long-term competitiveness. Develop and execute operational plans that support revenue growth, margin expansion, inventory optimization, and EBITDA performance. Foster a culture of accountability, engagement, continuous improvement, and operational excellence.

Operational Leadership Lead all operational functions including Production, Planning, Purchasing, Warehouse,

Shipping/Receiving,

and Maintenance. Drive performance through structured daily management systems, KPI accountability, and disciplined operational reviews. Ensure achievement of Safety, Quality, Delivery, Cost, Inventory, and People (SQDCIP) objectives. Develop scalable systems and processes capable of supporting significant organizational growth and increasing operational complexity. Establish clear performance expectations and accountability throughout the organization. Ensure operational resources, staffing, and infrastructure support current and future business requirements.

Technical Leadership & Engineering Partnership Serve as the primary operational leader responsible for translating engineering strategy into sustainable manufacturing execution. Partner closely with Engineering, Tooling, Automation, and Quality teams to improve manufacturing capability, process performance, equipment utilization, and operational efficiency. Provide operational leadership during new product introductions, validation activities, process transfers, equipment qualifications, and automation implementation. Drive data-driven decision-making, root cause analysis, structured problem solving, and process optimization initiatives. Support implementation of advanced manufacturing technologies and automation strategies that improve quality, productivity, and profitability. Champion technical excellence throughout the organization while fostering collaboration between operations and engineering teams.

Production & Manufacturing Execution Lead production operations through managers, supervisors, and functional leaders. Ensure achievement of production schedules, labor efficiency targets, throughput objectives, and customer delivery requirements. Drive improvements in Overall Equipment Effectiveness (OEE), capacity utilization, productivity, and manufacturing flow. Support continuous improvement initiatives focused on waste reduction, cycle time reduction, and operational effectiveness. Establish operational readiness plans to support business growth, product launches, and capacity expansion.

Planning, Purchasing & Materials Management Oversee production planning, inventory management, purchasing activities, warehouse operations, and shipping/receiving functions. Ensure alignment between customer demand, production capacity, and material availability. Drive inventory optimization while maintaining customer service and operational flexibility. Improve ERP/MRP discipline, inventory accuracy, planning effectiveness, and material flow. Partner with suppliers and internal stakeholders to mitigate supply chain risk and improve operational responsiveness.

Customer Focus & Cross-Functional Alignment Maintain a strong customer-first mindset by ensuring operational performance consistently supports customer expectations for quality, delivery, responsiveness, and service. Partner closely with Program Management, Customer Service, and Commercial teams to ensure customer requirements and commitments are effectively translated into operational execution. Support customer communications related to operational performance, capacity planning, quality initiatives, business continuity, and program execution when required. Participate in customer calls, audits, business reviews, site visits, and escalation discussions as needed to provide operational expertise and leadership support. Ensure operational priorities remain aligned with customer commitments and business objectives.

Transfer of Business, Capacity Expansion & Operational Readiness Lead operational planning and execution for transfer of products, equipment, and manufacturing processes from sister facilities or external locations. Ensure successful installation, qualification, validation, and ramp-up of new manufacturing equipment and technologies. Coordinate resources, staffing, training, and process readiness activities to support growth initiatives. Minimize operational disruption while ensuring customer delivery and quality expectations are maintained.

Quality & Regulatory Compliance Partner with Quality leadership to ensure compliance with ISO 13485, FDA requirements, and applicable regulatory standards. Promote a proactive quality culture focused on prevention, risk reduction, compliance, and continuous improvement. Support audit readiness, CAPA activities, validation programs, and regulatory inspections. Drive improvements in customer quality performance, scrap reduction, defect prevention, and process capability.

Maintenance & Asset Reliability Oversee preventive and predictive maintenance programs. Ensure equipment reliability, uptime, and asset utilization support operational requirements. Drive initiatives focused on downtime reduction, maintenance effectiveness, and equipment performance. Support capital equipment planning and lifecycle management activities.

Continuous Improvement Lead Lean Manufacturing and Continuous Improvement initiatives throughout the organization. Drive measurable improvements in:

Productivity Throughput Cycle Time Cost Reduction Waste Elimination Inventory Performance Labor Efficiency Operational Flow

Establish a culture of structured problem-solving and operational excellence.

People Leadership & Organizational Development Lead, coach, and develop operational leadership teams. Build organizational capability through succession planning, leadership development, and talent management. Foster a high-performance, people-first culture centered on accountability, collaboration, and continuous learning. Partner with Human Resources on workforce planning, engagement initiatives, performance management, and organizational development. Develop future leaders capable of supporting organizational growth and operational complexity.

Qualifications Education Bachelor's Degree in Engineering, Manufacturing, Operations Management, Business, or related field required. Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, Plastics Engineering, or related technical discipline strongly preferred. MBA or advanced degree preferred.

Experience 10+ years of progressive manufacturing leadership experience within injection molding, medical device manufacturing, plastics, or other highly regulated manufacturing environments. Minimum 5 years of senior operations leadership experience with responsibility for multiple manufacturing functions. Proven experience leading complex manufacturing organizations through growth, transformation, and operational scaling. Strong experience with:

New Product Introduction (NPI) Process Validation (IQ/OQ/PQ) Manufacturing Transfers Automation Implementation Capacity Expansion Continuous Improvement

Medical device manufacturing experience strongly preferred. Injection molding experience strongly preferred. Experience with ERP/MRP systems such as IQMS, Epicor, or equivalent preferred .

Technical & Leadership Competencies Technical Expertise Strong technical aptitude with the ability to understand, challenge, and influence engineering, tooling, automation, quality, and manufacturing decisions. Working knowledge of injection molding processes, scientific molding principles, process validation methodologies, tooling systems, automation technologies, and manufacturing controls. Ability to lead highly technical teams while translating technical concepts into operational execution and business results. Strong analytical and problem-solving capabilities supported by data-driven decision-making. Leadership Proven ability to lead large, multi-functional manufacturing organizations. Strong executive presence with the ability to influence at all organizational levels. Demonstrated success developing leaders and building high-performance teams. Strong change management, organizational development, and transformation leadership capabilities. Business Acumen Strong understanding of:

P&L Management EBITDA Performance Inventory Management Operational Finance Capital Planning Cost Management

Ability to balance operational excellence with financial performance and long-term strategic growth.