Senior Director, Manufacturing

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