Manufacturing Growth & Capacity Leader for Medical Devices

Enable Injections, Inc.; Cincinnati (OH); On-site; USD 180,000 - 260,000; Full time

Job summary

Enable Injections, Inc. is seeking a Senior Director of Manufacturing onsite in Cincinnati to lead all shop floor operations, ensuring safe, compliant, and efficient production. You will own capital planning, capacity expansion, and supplier collaboration with Engineering and Product Development.

The role requires deep experience in high-volume medical device manufacturing, GMP/GDP standards, and a proven track record in leading growth while developing a high-performing team.

Qualifications

• Bachelor's degree in engineering or an equivalent combination of education and experience.
• 15 years of disposable medical device manufacturing experience in high-volume ops.
• Proven ability to scale and optimize shop floor capacity.
• Knowledge of GMP/GDP, FDA QMSR, ISO 13485 requirements.
• Strong manufacturing metrics and data-driven decision making.
• Proven people development and cross-functional leadership.
• Experience with capital projects, budgeting, and ERP systems.

Responsibilities

• Develop Enable's manufacturing strategy with senior management.
• Own Manufacturing and Facilities, ensuring safe, compliant operations.
• Collaborate with Engineering to implement capacity plans and capital equipment.
• Execute build plans to meet forecasted product supply.
• Create and manage manufacturing budgets and tracking metrics.
• Set clear objectives for stations and floor teams with measurable KPIs.
• Increase yield, capacity, and reduce overall costs of goods.
• Lead the manufacturing organization with a clear, actionable vision.
• Develop leaders and coach direct reports for career growth.
• Ensure CAPA, risk management, and validation activities comply with FDA QMSR and ISO 13485.
• Maintain and monitor safety, quality, delivery, and cost metrics.
• Support EH&S programs and regulatory inspections.

Skills

Lean Manufacturing

CAPA

Risk Management (ISO 14971)

Process Validation (IQ/OQ/PQ)

People Development

Production Planning & Scheduling

Verbal & Written Communication

Team Leadership

Data & Metrics Mindset

Education

Bachelor's degree in Engineering or equivalent

Master's degree (preferred)

Job description

Enable Injections, Inc. is seeking a Senior Director of Manufacturing onsite in Cincinnati to lead all shop floor operations, ensuring safe, compliant, and efficient production. You will own capital planning, capacity expansion, and supplier collaboration with Engineering and Product Development.

The role requires deep experience in high-volume medical device manufacturing, GMP/GDP standards, and a proven track record in leading growth while developing a high-performing team.