Operations Manager – Production

Natus Sensory Inc.; Galway; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Natus Sensory Inc. is seeking an Operations Manager to lead global electro-mechanical medical device production. You will drive operational excellence through Lean and Six Sigma methods, oversee cost reduction, and ensure quality and regulatory compliance across multiple sites.

You will partner with Supply Chain, Engineering, Quality, Regulatory, and Customer Service to improve productivity, lead times, and customer satisfaction while supporting growth and profitability.

Qualifikationen

• Bachelor's degree in Engineering or related technical field.
• 7+ years of progressive operations leadership experience in manufacturing or regulated environment.
• Strong technical understanding of electro-mechanical products and manufacturing processes.
• Proven Lean Manufacturing and continuous improvement experience with measurable results.
• Experience with Make vs. Buy analyses and strategic sourcing.
• ERP/MRP systems knowledge and manufacturing metrics familiarity.
• Excellent leadership, communication, and cross-functional collaboration.

Aufgaben

• Lead global production operations to meet safety, quality, delivery, and cost targets.
• Develop and execute global strategies to improve productivity, capacity, throughput, and performance.
• Drive CI initiatives using Lean, Six Sigma, Kaizen, VSM, 5S, and other methodologies.
• Identify and implement productivity and cost-reduction projects without compromising quality.
• Improve lead times and customer responsiveness while supporting growth.
• Establish KPIs for manufacturing, quality, delivery, inventory, and service.
• Lead Make vs. Buy analyses to optimize manufacturing strategy and total cost of ownership.
• Collaborate with Supply Chain, Engineering, Quality, Regulatory, and Customer Service teams.

Jobbeschreibung

Summary

The Operations Manager is responsible for leading production operations for a portfolio of electro-mechanical medical devices. This role is accountable for delivering operational excellence through continuous process improvement, lean manufacturing principles, and strategic cost reduction initiatives while ensuring the highest standards of quality, regulatory compliance, customer satisfaction, and employee engagement.

The ideal candidate combines a strong engineering and technical background with proven operational leadership experience in a regulated manufacturing environment. This individual will drive productivity improvements, optimize production processes, improve lead times, and enhance customer responsiveness while supporting business growth and profitability.

Key Responsibilities

• Lead daily global production operations to ensure safety, quality, delivery, and cost objectives are consistently achieved.
• Develop and execute global operational strategies that improve productivity, capacity utilization, throughput, and overall operational performance.
• Drive continuous improvement initiatives using Lean Manufacturing, Six Sigma, Kaizen, Value Stream Mapping, 5S, and other operational excellence methodologies.
• Identify, prioritize, and implement productivity and cost reduction projects that improve profitability without compromising quality or compliance.
• Improve manufacturing and production lead times while increasing responsiveness to customer demand and service requirements.
• Establish and monitor key performance indicators (KPIs) for manufacturing, quality, delivery performance, inventory, and customer service.
• Lead Make vs. Buy analyses to optimize manufacturing strategy, supply chain performance, and total cost of ownership.
• Partner with Supply Chain, Engineering, Quality, Regulatory, and Customer Service teams to improve operational performance and resolve production or service issues.
• Support new product introductions by ensuring manufacturing, process capability, and operational scalability.
• Evaluate and implement automation, tooling, process improvements, and technology solutions that increase efficiency and reduce operating costs.
• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and all applicable regulatory and quality requirements.
• Develop standard work, operating procedures, and process documentation that promote consistency and operational excellence.
• Partner with team to establish processes for demo equipment management and refurbished equipment and spare parts.
• Lead, coach, and develop operation production teams while fostering a culture of accountability, collaboration, continuous improvement, and employee engagement.
• Manage departmental budgets, capital expenditures, staffing plans, and operational resources to achieve business objectives.

Qualifications

Required

• Bachelor's degree in Engineering (Mechanical, Electrical, Industrial, Manufacturing, or related discipline) or equivalent technical degree.
• 7+ years of progressive operations leadership experience in manufacturing or service repair, preferably within the medical device or other highly regulated industry.
• Strong technical understanding of electro-mechanical products, assemblies, and manufacturing processes.
• Demonstrated success leading Lean Manufacturing and continuous improvement initiatives with measurable business results.
• Proven experience driving productivity improvements, cost reduction, and operational efficiency.
• Experience improving production and repair lead times through process optimization and workflow redesign.
• Strong analytical and problem-solving skills with the ability to use data to drive operational decisions.
• Experience performing Make vs. Buy analyses and supporting strategic sourcing decisions.
• Working knowledge of ERP/MRP systems and manufacturing performance metrics.
• Excellent leadership, communication, and cross-functional collaboration skills.

Preferred

• Master's degree in Engineering, Operations Management, or Business Administration.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with FDA-regulated medical device manufacturing and ISO 13485 quality systems

Key Competencies

• Operational Excellence
• Lean Manufacturing
• Continuous Improvement
• Process Optimization
• Engineering and Technical Leadership
• Electro-Mechanical Systems
• Productivity Improvement
• Cost Reduction
• Value Stream Mapping
• Root Cause Analysis
• Change Management
• Strategic Planning
• Customer Focus
• Cross-Functional Leadership
• Data-Driven Decision Making

Success Measures

Success in this role will be measured by the ability to:

• Increase manufacturing and depot repair productivity.
• Reduce operating costs and improve gross margin.
• Improve manufacturing and repair turnaround times.
• Increase on-time delivery and customer responsiveness.
• Successfully implement Lean initiatives that eliminate waste and improve process capability.
• Optimize sourcing decisions through effective Make vs. Buy analysis.
• Build a high-performing, engaged operations team focused on continuous improvement and operational excellence.