Manufacturing Engineering Manager
December 18, 2006
Material Management & Supply Chain
233MW-06
RESPONSIBILITIES:
Process
· Oversees the application of lean manufacturing principles in the operations including the process layouts, assembly equipment, process flow, and any interfacing with the Facilities department for physical plant resource issues.
· Responsible for documentation for all manufacturing production lines, to assure there is properly documented change control and documents are compliant with FDA requirements.
· Ensure the complete and timely resolution of NCI's and CAs related to process and equipment issues.
· Applies the Six Sigma methodology to help reduce variation, improve quality and establish lasting process controls.
· Ensures that all production and test equipment is functional, well maintained and available.
· Ensures seamless transition of new products from NPE to Operations.
Organizational
· Work with manufacturing supervisors, production manager and lean manager to achieve lean goals and objectives.
· Provide training, mentoring, guidance, and high performance example to staff.
· Maintain communication of manufacturing issues to management.
· Staffing and development of Engineers/Technicians for building and maintaining manufacturing and test equipment.
· Review manufacturing issues across all production lines and adjust resource allocation accordingly.
· Proactively identify problems and be a change agent to finding resolution
· Manages budget, projects, and capital expenditures per plan and uses required financial processes in managing the organization.
· Acts as change agent in the use of statistically based decision making throughout the mfg organization.
Projects
· Instills best practices in organization in project management and use of project management tools
· Actively tracks project progress for team, coaches and mentors with goal of completing on time and on budget
· Keeps an active watch on resource allocation and ability to keep engineering team focused on top priority projects.
· Mentors engineers on scoping, selecting, implementing and IQ/OQ/PQ capital equipment installations for molding, assembly, test and chemical and drug processing equipment.
· Other projects as assigned by Director.
QUALIFICATIONS:
EDUCATION
· BS in Engineering required. Mini-MBA, MBA, or other financial business coursework preferred.
EXPERIENCE
· Minimum 15 years of progressive Engineering experience.
· Minimum 10 years Medical Device Manufacturing experience.
· Minimum 8 years Engineering Management experience.
· Knowledge of regulations and standards involving FDA, ISO, GMP, etc.
· Experience conducting performance appraisals, recruiting, and handling disciplinary/improvement activities with staff employees.
· Demonstrated ability in developing employees in a high performance environment.
· Lean and Six Sigma experience a plus.
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