Manufacturing Excellence Leader, NPI & Automation

DSJ Global; Massachusetts; On-site; USD 180,000 - 240,000; Full time

Job summary

DSJ Global is seeking a senior manufacturing leader for a rapidly growing medical device client. This role will steer manufacturing strategy, scale operations, and drive efficiency while ensuring patient safety and regulatory compliance.

The leader will oversee Manufacturing, Manufacturing Engineering, Technical Operations, Automation, and NPI, collaborating with executives to optimize capacity, quality, and cost in a regulated environment.

Qualifications

• Bachelor's degree in Engineering or related technical discipline required.
• 12+ years of leadership in manufacturing/operations within a regulated medical device environment.
• Proven track record scaling manufacturing orgs during growth and complexity increases.
• 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 quality systems.
• Experience leading Lean Manufacturing and Continuous Improvement initiatives with measurable results.
• Ability to lead cross-functional teams, manage capital investments, and build high-performing orgs.

Responsibilities

• Set Manufacturing Strategy and roadmap to support growth, capacity expansion, launches, and objectives.
• Own Production & Operational Performance with focus on throughput, yield, cycle time, on-time delivery, productivity, and cost.
• Lead Manufacturing Engineering, Technical Operations, and Automation initiatives; develop processes, control plans, and specs.
• Oversee NPI and Design Transfer activities ensuring manufacturability and scale.
• Build a high-performing organization through recruitment, mentorship, and culture of excellence.
• Ensure Quality, Compliance & Safety with FDA/ISO 13485 adherence and proactive validation & CAPA.

Skills

Leadership

Strategic planning

Cross-functional collaboration

Lean Manufacturing

Six Sigma/CPPS

Education

Bachelor's degree in Engineering

Master's degree or MBA preferred

Job description

DSJ Global is seeking a senior manufacturing leader for a rapidly growing medical device client. This role will steer manufacturing strategy, scale operations, and drive efficiency while ensuring patient safety and regulatory compliance.

The leader will oversee Manufacturing, Manufacturing Engineering, Technical Operations, Automation, and NPI, collaborating with executives to optimize capacity, quality, and cost in a regulated environment.