Senior Director​/Head of Manufacturing & Operations

Our client is a rapidly growing medical device manufacturer seeking a strategic and hands-on manufacturing leader to scale operations, strengthen technical capabilities, and drive operational excellence. This role will lead Manufacturing, Manufacturing Engineering, Technical Operations, Automation, and New Product Introduction (NPI), ensuring production systems can support significant growth while maintaining the highest standards of quality, compliance, and patient safety.

The successful candidate will partner closely with executive leadership to improve capacity, throughput, quality, and cost performance while building a scalable, world-class manufacturing organization within a regulated medical device environment.

Set Manufacturing Strategy

• Develop and execute the manufacturing roadmap to support growth, capacity expansion, product launches, and operational objectives.
• Partner with Engineering, Quality, Supply Chain, Finance, and Commercial teams on long-range planning and capital investment strategies.
• Provide leadership on manufacturing performance, operational risks, and scalability initiatives.

Own Production & Operational Performance

• Lead manufacturing operations with a Quality First mindset and commitment to patient safety.
• Drive improvements in throughput, yield, cycle time, on-time delivery, productivity, and cost.
• Establish performance metrics, escalation processes, and accountability systems across a multi-shift manufacturing environment.
• Build strong frontline leadership focused on root-cause problem solving and continuous improvement.

Lead Manufacturing Engineering & Technical Operations

• Oversee Manufacturing Engineering, Process Engineering, Equipment Engineering, Validation, and Continuous Improvement functions.
• Develop robust manufacturing processes, control plans, work instructions, and technical standards.
• Apply Lean Manufacturing, Six Sigma, DOE, and statistical methodologies to improve process capability and operational performance.
• Lead process validation, equipment qualification, risk management, and manufacturing controls.
• Develop and execute automation strategies that improve scalability, quality, repeatability, and labor efficiency.
• Lead equipment selection, tooling development, robotics, vision systems, and capital equipment projects.
• Partner with external vendors and integrators to deploy advanced manufacturing technologies and automation solutions.

Lead NPI & Design Transfer

• Partner with Product Development and Quality to ensure products are designed for manufacturability, quality, and scale.
• Own manufacturing readiness activities for new product introductions and design transfers.
• Ensure successful process validation, production qualification, and commercialization of new products.

Build a High-Performing Organization

• Recruit, develop, and mentor engineering and operations teams.
• Establish a culture of operational excellence, accountability, safety, and continuous improvement.
• Build organizational capabilities that support future growth and succession planning.

Ensure Quality, Compliance & Safety

• Ensure compliance with FDA Quality System Regulations, ISO 13485, and applicable regulatory requirements.
• Partner with Quality to support audits, inspections, CAPA, change control, risk management, and validation activities.
• Promote a culture where quality is built into every process and manufacturing decision.

• Bachelor's degree in Engineering or a related technical discipline;
  Master's degree or MBA preferred.
• 12+ years of manufacturing, engineering, or operations leadership experience within a regulated medical device environment.
• Proven success scaling manufacturing organizations through periods of rapid growth and increasing complexity.
• Strong background in Manufacturing Engineering, Technical Operations, Process Validation, Automation, and NPI.
• Deep knowledge of FDA regulations, ISO 13485, design transfer, validation, risk management, and manufacturing quality systems.
• Experience leading Lean Manufacturing and Continuous Improvement initiatives that drive measurable operational results.
• Demonstrated ability to lead cross-functional teams, manage capital investments, and build high-performing organizations.