Head of Manufacturing - Medical Devices & Growth

Cintrifuse; Cincinnati (OH); On-site; USD 180,000 - 230,000; Full time

Job summary

Cintrifuse in Cincinnati, OH, is seeking a senior manufacturing leader to own and optimize all shop floor operations, drive capacity planning, and ensure compliance with FDA QMSR, GMP/GDP, and ISO 13485.

The role partners with Engineering, Product Development, and senior management to develop manufacturing strategy, improve yield, reduce costs, and scale production in a high-growth environment. Onsite position with extensive regulatory experience required.

Qualifications

• Bachelor's degree in engineering or equivalent with strong manufacturing background.
• 15 years of disposable medical device manufacturing experience in high-volume operations.
• Experience building and growing manufacturing and shop floor operations.
• Knowledge of GMP/GDP, FDA QMSR and ISO 13485 requirements.
• Strong manufacturing metrics and people development skills.
• Project management and leadership experience.
• Experience supervising manufacturing floor and developing others.

Responsibilities

• Develop Enable's manufacturing strategy with senior management.
• Own Manufacturing and Facilities including all shop floor activities.
• Collaborate with Engineering/Product Development to plan capex and capacity.
• Execute build plans to meet forecasted requirements.
• Develop and manage manufacturing budgets and plans.
• Create clear objective metrics for floor operations.
• Increase yield and capacity while reducing costs.
• Lead the manufacturing organization and ensure execution of plans.
• Mentor and coach direct reports to maximize talent.
• Oversee CAPA, risk management, and process validation for compliance with FDA QMSR, ISO 13485, and GMP/GDP.

Skills

Disposables manufacturing

15 years experience

People development

Project management

GMP/GDP & QMSR ISO13485

Lean manufacturing

CAPA

Risk management

IQ/OQ/PQ

FDA regulatory knowledge

Education

Bachelor's degree in Engineering or equivalent

Master's degree (preferred)

Tools

ERP systems

Equipment maintenance & validation

CAPA tracking tools

Job description

Cintrifuse in Cincinnati, OH, is seeking a senior manufacturing leader to own and optimize all shop floor operations, drive capacity planning, and ensure compliance with FDA QMSR, GMP/GDP, and ISO 13485.

The role partners with Engineering, Product Development, and senior management to develop manufacturing strategy, improve yield, reduce costs, and scale production in a high-growth environment. Onsite position with extensive regulatory experience required.