Direct and coordinate the planning and management of the Manufacturing Engineering department including existing production processes and operations, manufacturing process development, risk analysis, design control, sterilization requirements, process and design validations.
· Determine and review all manufacturing processes for cost effectiveness and feasibility, both before and after engineering releases to manufacturing.
· Coordinate all engineering releases and changes relative to routings, setting standards, data entry, and follow up.
· Identify new manufacturing or product technologies for review and possible development activities within the manufacturing engineering group.
· Determine priorities with the Operations Manager, and implement cost-reduction projects; maintain detailed documentation as required.
· Assure work force utilization, facility layout and operational data such as production costs, process flow charts and production schedules determine efficient utilization of workers and equipment.
· Define new processes and “fit” with the current core competencies within company. The ability to accurately assess timing and costs for new projects is critical.
· Prepare all departmental budgets as necessary; ensure conformance as required.
· Carry out the management responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
· Review analyses of activities, costs, operations, and forecast data to determine Manufacturing Engineering department progress toward stated goals and objectives.
· Participate in formulating and administering company policies and developing long-range goals and objectives.
· Participation in the overall manufacturing engineering program management system including regular meetings and discussions around project priorities and status updates.
· Serve as member of management committees on special studies.
· Responsible for the management of all manufacturing, industrial engineering staff, machine shop and maintenance department.
· Communicate openly and often with cross-functional management staff to evaluate production process needs, resolve problems and obstacles, provide resources, reset direction and maximize effective interactions and functioning.
· Constructively challenge, and actively participate in, management decision-making processes related to strategic and tactical business issues.
· Articulate vision/strategy to company leaders, peers and subordinates and gain commitment as well as influence behaviors to drive results.
· Foster and maintain relationships with key external vendors and/or associations.
· Effectively drive teamwork up, across and down the organization to deliver results.
EDUCATION AND/OR EXPERIENCE
· Bachelor’s degree in Engineering or Industrial Management and 7-10 years related engineering experience or any other combination of education and/or experience necessary to complete the essential functions of the position. Advanced degree preferred.
· Seven to ten years’ management experience preferably in a FDA/GMP regulated industry (Pharmaceutical, medical devices or food).
· Background in injection molding, medical device assembly, automation assembly and packaging used in the manufacture of products preferred.
· Experience in the application of statistical techniques such as statistical process control, design of experiments, and problem-solving techniques is required.
· Experience with design, review, execution, and approval of Installation, operation and Process qualification protocols and reports (IQ/OQ/PQ).