Manufacturing Strategy Director – Medical Devices

Parkview Medical Center, Inc.; Cincinnati (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Parkview Medical Center, Inc. is seeking an experienced manufacturing leader to drive the company's production strategy on the Cincinnati campus. You will own all shop floor operations, partner with Engineering to scale capacity, and ensure safety, quality, and regulatory compliance across GMP/GDP environments.

The ideal candidate brings 15+ years in medical device manufacturing, Lean and Six Sigma expertise, and a proven track record in growth and optimization of production capacity.

Qualifications

• Bachelor's degree or higher in engineering or related field.
• 15+ years of medical device manufacturing experience in high-volume, medium-to-complex operations.
• Track record of organizing and building manufacturing and shop floor operations that scale production capacity.
• Strong knowledge of GMP/GDP regulatory requirements, including FDA QMSR and ISO 13485.
• Strong manufacturing metrics knowledge and leadership abilities.

Responsibilities

• Develop Enable's manufacturing strategy with senior management.
• Own Manufacturing and Facilities, including all shop floor activities, ensuring safe, compliant, and efficient operations.
• Collaborate with Engineering and Product Development to implement capital equipment and capacity plans.
• Execute build plans to ensure adequate product supply to meet forecasted requirements.
• Develop manufacturing plans and budgets, and ensure execution.
• Maintain and improve manufacturing metrics for safety, quality, delivery, and cost.
• Lead and develop a high-performance manufacturing and shop floor team.
• Oversee CAPA, risk management, and process validation activities per FDA QMSR, ISO 13485, and GMP/GDP.

Skills

Lean Manufacturing

Six Sigma

CAPA

Risk Management

Process Validation (IQ/OQ/PQ)

Leadership

Verbal & written communication

Production Planning & Scheduling

Education

Bachelor's degree in Engineering or related field

Tools

GMP/GDP regulatory knowledge

ERP systems

Regulatory familiarity (FDA QMSR, ISO 13485)

Job description

Parkview Medical Center, Inc. is seeking an experienced manufacturing leader to drive the company's production strategy on the Cincinnati campus. You will own all shop floor operations, partner with Engineering to scale capacity, and ensure safety, quality, and regulatory compliance across GMP/GDP environments.

The ideal candidate brings 15+ years in medical device manufacturing, Lean and Six Sigma expertise, and a proven track record in growth and optimization of production capacity.