Job Description
Job Description
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
Experience10+ 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