|
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:
- 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
|
