Senior Director, Manufacturing

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

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• Bachelor's degree with a preference in Engineering,or equivalent combination of education and experience
• 15 years ofdisposablemedical device manufacturing experience in high-volume, medium-to-complex operations
• A track recordof successfully organizing and building fully functioning manufacturing and shop floor operations capable of growing andoptimizingproduction capacity
• Knowledge of current regulatory requirements for GMP/GDP, including FDA's Quality Management System Regulation (QMSR) and ISO 13485
• Strong knowledge of manufacturing metrics
• Managing and developing others

Preferred:

• 20+ years of medical device manufacturing experience
• Six Sigma Black Belt ordemonstratedcontinuous improvement skill set
• Equipment maintenance and validation experience in a regulated environment
• Budgeting,ERPand inventory management experience
• Experience with automated equipment and common product and device assembly methods
• Demonstrated experience leading manufacturing operations through a period of significant company growth
• Direct experience supervising manufacturing floor operations and operators
• Familiarity with Clean Room Environments
• Lean Manufacturing and continuous improvement methodologies
• CAPA (Corrective and Preventive Action) process ownership
• Risk Management (e.g., ISO 14971) applied to manufacturing processes
• Process Validation (IQ/OQ/PQ)methodology
• Identifyingand developing manufacturing and shop floor talent
• Production Operation Staffing and Scheduling
• Verbal and written communication
• Developing effective technical and business presentations
• Managing resources in a dynamic, high-growth environment

Physical Requirements:

• Must be able to remain in a stationary position for extended periods of time
• Ability to constantlyoperatea computer and other office equipment, such asprinter,telephone, etc.
• Ability to work on the manufacturing floor, including ingowned/cleanroom environments, for extended periods of time

RESPONSIBILITIES:

• Work with senior management to develop Enable's manufacturing strategy
• Participate in development of company business systems & work environment
• Own Manufacturing and Facilities, including all shop floor activities, ensuring safe,compliant, and efficient operations
• Work with Engineering and Product Development to implement a capital equipment and manufacturing capacity plan
• Execute buildplans toassureadequate product supply to meet forecasted requirements
• Develop overall manufacturing plans, budgets & ensure execution
• Develop easily understandable and specific objective metrics for positions,stationsand overall floor operations
• Increase yield and capacity and decrease overall COGs
• Lead the manufacturing organization, including all shop floor operations, with a clear, direct vision
• Ensure team leaders develop achievable work plans
• Motivate and lead a high-performance manufacturing and shop floor team
• Supervise, develop, mentor and coach direct reports in maximizing their talent and career potential
• Own CAPA, risk management, and process validation activities for manufacturing and shop floor operations, ensuring compliance with FDA QMSR, ISO 13485, and GMP/GDP requirements
• Assess efficiency of product manufacturing systems; develop & implement improvement plansutilizingLean Manufacturing and Six Sigma methodologies
• Maintain and update manufacturing metrics to track safety, quality, quantity,deliveryand cost information
• Other responsibilities may be assigned & not all responsibilities listed may be assigned
• Develop, deliver, and own EH&S training for new hire onboarding and ongoing employee education
• Track, analyze, and report EH&S metrics (TRIR, near-misses, corrective actions) to site and executive leadership
• Lead or support ergonomics assessments and industrial hygiene monitoring (noise, air quality, chemical exposure)
• Maintain OSHA recordkeeping (Forms 300, 300A, 301) and ensure timely regulatory reporting
• Serve as primary point of contact for EH&S regulatory agency inspections and audits
• Support environmental compliance programs, including waste management, air permits, and stormwater management
• Champion a proactive safety culture through employee safety committees and recognition programs
• Support corporate Vision and manage using the corporate values
• Other responsibilities may be assigned, not all responsibilities listed may be assigned