Medical Manufacturing Operations Manager - Injection Molding

We are seeking a strategic, customer-focused Operations Manager to lead and optimize manufacturing operations within a growing medical device Injection Molding Center of Excellence. This role is responsible for end-to-end operational execution across Production, Planning, Materials, Warehouse, Shipping/Receiving, Manufacturing Engineering partnership, Quality partnership, and Maintenance, while driving operational excellence, organizational capability, customer satisfaction, and profitable growth.

 

As a key member of the Senior Leadership Team, this individual will contribute to business strategy, operational scalability, financial performance, and long-term growth initiatives. The Operations Manager will play a critical role in New Product Introduction (NPI), process validation, transfer of business activities, automation expansion, and integration of new equipment and manufacturing technologies.

 

The ideal candidate combines strong operational leadership, technical expertise, business acumen, and people leadership experience within regulated manufacturing environments. This individual must be highly collaborative, customer-facing, and capable of building a high-performance, accountable culture focused on Safety, Quality, Delivery, Cost, Inventory, and People (SQDCIP).

 

This position is viewed as a key succession role with future growth potential into broader site or General Manager leadership responsibilities.

 

Key Responsibilities

Strategic Leadership & Business Partnership

• Serve as a key member of the Senior Leadership Team contributing to:
  • Business strategy and long-term operational planning
  • Annual operating plans and goal deployment
  • Organizational design and capability building
  • Capacity expansion and operational scalability
  • Capital investment and automation strategy
• Partner with the General Manager and leadership team to support profitable growth initiatives and long-term business objectives
• Drive accountability, alignment, and collaboration across all operational and support functions
• Support development of a high-performance, people-first culture focused on engagement, accountability, and continuous improvement
• Participate in strategic planning, forecasting, quoting, and operational readiness discussions tied to new business opportunities

 

Operational Leadership

• Lead plant operations across Safety, Quality, Delivery, Cost, Inventory, and People (SQDCIP)
• Drive execution through structured daily management systems, KPI accountability, and operational reviews
• Develop scalable operational systems and processes capable of supporting significant business growth
• Build a culture of operational excellence, collaboration, urgency, and accountability
• Ensure alignment between operational performance, customer expectations, and financial objectives
• Lead operational readiness and capacity planning initiatives to support growth and expansion

 

Production & Manufacturing Execution

• Lead production operations through Production Managers, Supervisors, and functional leadership teams
• Ensure achievement of production targets with focus on:
  • Efficiency
  • Throughput
  • Labor utilization
  • Schedule attainment
  • Capacity optimization
• Optimize performance within a high-volume, labor-intensive manufacturing environment
• Drive measurable improvements in:
  • OEE
  • Productivity
  • Operational flow
  • Cycle time reduction
  • Scrap reduction
• Support implementation of automation and manufacturing technology initiatives

 

Planning, Materials & Supply Chain Operations

• Oversee production planning, scheduling, inventory control, warehouse operations, and shipping/receiving
• Ensure alignment between customer demand, production capacity, and material availability
• Partner with Purchasing and Supply Chain teams to improve:
  • Supplier performance
  • Inventory optimization
  • Delivery execution
  • ERP/MRP discipline
• Improve inventory accuracy, operational responsiveness, and production scheduling effectiveness
• Support strategies to mitigate supply chain risk and improve operational continuity

 

Engineering, NPI & Validation Leadership

• Partner closely with Manufacturing Engineering and Program Management teams to support operational readiness and manufacturing execution
• Support New Product Introduction (NPI) and product transfers into manufacturing
• Ensure Design for Manufacturability (DFM) principles are incorporated into manufacturing processes
• Lead and support validation activities including:
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)
• Ensure successful launch of new products, equipment, and manufacturing processes while meeting quality, delivery, and cost expectations
• Coordinate effectively across Engineering, Tooling, Quality, and Operations functions

 

Transfer of Business & Capacity Expansion

• Lead transfer of products, equipment, tooling, and processes from sister sites or external manufacturing locations
• Oversee installation, qualification, and ramp-up of new machines and manufacturing technologies
• Ensure smooth operational transitions with minimal disruption to quality and customer delivery
• Align staffing, training, process readiness, and operational resources to support business growth and expansion
• Support facility and manufacturing scalability initiatives

 

Customer Engagement & Cross-Functional Collaboration

• Serve as a key operational leader in customer-facing activities including:
  • Business reviews
  • Technical discussions
  • Audits
  • Site visits
  • Escalation management
• Build strong customer relationships centered on responsiveness, operational excellence, and partnership
• Partner closely with Commercial, Program Management, Customer Service, Planning, Engineering, and Quality teams to support customer growth and operational success
• Support quoting, capacity planning, and operational strategy discussions tied to new business opportunities

 

Quality & Regulatory Compliance

• Partner closely with Quality leadership to ensure compliance with:
  • ISO 13485
  • FDA regulations
  • Customer-specific requirements
  • Applicable medical device regulations
• Support initiatives focused on reducing:
  • Defects
  • Scrap
  • Customer complaints
  • Operational risk
• Promote a proactive quality culture across operations
• Ensure operational support for audits, inspections, CAPA activities, and regulatory compliance initiatives
• Drive structured root cause analysis and corrective action implementation

 

Maintenance & Equipment Reliability

• Oversee preventive and predictive maintenance programs
• Ensure high levels of equipment uptime, reliability, and asset utilization
• Drive improvements in:
  • Downtime reduction
  • Equipment performance
  • Maintenance responsiveness
• Support capital equipment planning, installation, and operational integration

 

Continuous Improvement

• Lead Lean Manufacturing and Continuous Improvement initiatives across operations
• Drive measurable improvements in:
  • Throughput
  • Cycle time
  • Waste elimination
  • Labor efficiency
  • Cost reduction
  • Operational flow
• Establish a culture of structured problem-solving and operational excellence
• Utilize Lean tools, data analytics, and KPI management to drive sustainable improvements

 

People Leadership & Organizational Development

• Lead, coach, and develop operational leadership teams
• Build a high-performance, people-focused culture centered on:
  • Accountability
  • Engagement
  • Teamwork
  • Leadership development
  • Continuous learning
• Drive succession planning and organizational capability development
• Partner with HR to support:
  • Workforce planning
  • Employee engagement
  • Performance management
  • Talent development
• Develop future leaders capable of supporting organizational growth and operational scalability

 

Financial & Operational Performance

• Develop and manage operational budgets and cost performance
• Drive operational efficiency and cost improvement initiatives
• Demonstrate strong business and financial acumen with focus on:
  • P&L awareness
  • EBITDA performance
  • Inventory management
  • Operational finance
  • Margin improvement
• Utilize KPIs and data analytics to support operational and strategic decision-making
• Support capital planning, investment analysis, and operational forecasting activities

 

Qualifications

Education

• Bachelor's degree in Engineering, Operations Management, Manufacturing, Business, or related field required
• MBA or advanced degree preferred

 

Experience

• 10+ years of manufacturing leadership experience within:
  • Medical device manufacturing
  • Injection molding
  • Plastics manufacturing
  • Highly regulated manufacturing environments
• Minimum 5 years in a senior manufacturing or operations leadership role
• Proven experience leading multi-functional manufacturing organizations
• Strong experience with:
  • New Product Introduction (NPI)
  • Process validation (IQ/OQ/PQ)
  • Transfer of business and equipment between sites
  • Operational scaling and organizational growth
• Experience in medical device manufacturing strongly preferred
• Injection molding experience strongly preferred
• Experience with ERP/MRP systems such as IQMS or Epicor preferred

 

Technical & Leadership Competencies

• Strong expertise in:
  • Manufacturing operations
  • Process improvement
  • Validation methodologies
  • Regulated manufacturing environments
  • Lean Manufacturing / Continuous Improvement
  • Operational scalability and transformation
• Strong business and financial acumen with demonstrated understanding of:
  • P&L management
  • EBITDA drivers
  • Inventory management
  • Operational finance
• Proven ability to build and scale operational organizations within a growing manufacturing environment
• Strong customer-facing leadership capability with the ability to engage effectively with customers, executive leadership, and cross-functional teams
• Excellent communication, organizational, and strategic planning skills
• Demonstrated ability to develop leaders, build teams, and drive accountability
• Strong change management and transformation leadership capability

 

Preferred Leadership Characteristics

• Strategic thinker with strong operational execution capability
• Collaborative, hands-on leader who thrives in fast-paced manufacturing environments
• Customer-focused with strong relationship-building skills
• Data-driven decision maker with continuous improvement mindset
• High level of accountability, urgency, and ownership
• Passion for building teams, developing people, and driving organizational growth