Senior Director, Manufacturing (Cincinnati, OH, US, 45241)

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

Location: Onsite

Status Type: Full Time

QUALIFICATIONS

Required:

• Bachelor's degree with a preference in Engineering, or equivalent combination of education and experience
• 15 years of disposable medical device manufacturing experience in high-volume, medium-to-complex operations
• A track record of successfully organizing and building fully functioning manufacturing and shop floor operations capable of growing and optimizing production 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
• Strong People Development skills
• Strong Project Management skills
• Managing and developing others

Preferred:

• Master's degree
• 20+ years of medical device manufacturing experience
• Combination product experience
• Six Sigma Black Belt or demonstrated continuous improvement skill set
• Equipment maintenance and validation experience in a regulated environment
• Budgeting, ERP and 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

Skills & Competencies:

• 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
• Identifying and 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 constantly operate a computer and other office equipment, such as printer, telephone, etc.
• Ability to work on the manufacturing floor, including in gowned/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 build plans to assure adequate product supply to meet forecasted requirements
• Develop overall manufacturing plans, budgets & ensure execution
• Develop easily understandable and specific objective metrics for positions, stations and 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 plans utilizing Lean Manufacturing and Six Sigma methodologies
• Maintain and update manufacturing metrics to track safety, quality, quantity, delivery and 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