Supervisor Manufacturing Engineering

Manages manufacturing activities in an FDA regulated environment in order to meet production schedules, quality standards and cost objectives. Executes manufacturing schedules according to needs determined by the Planning department. Provides input to budgets. Participates in selection of personnel, conducts performance reviews and writes development plans for non-exempt staff. Plans, leads, and executes technical manufacturing engineering activities to improve safety, quality, cost, and delivery.

Main Responsibilities:

• Responsible for directing the people conducting manufacturing operations which result in the production of high quality products.
• Works to ensure that customer expectations for product availability are achieved.
• Develops of annual resource requirements including financial, personnel and capital requirements.
• Responsible to recruit, train and develop the personnel.
• Guides the staff in the annual performance assessment process, which includes conducting feedback sessions and establishing goals.
• Provides the operational guidance necessary to promote excellence in the areas of manufacturing and process development.
• Provides technical expertise to the manufacturing group when addressing technical issues.
• Serves on one or more multi-disciplinary (R&D, QA, Clinical and Commercial) project teams in support of new product development efforts to ensure activities are transferred to operations smoothly and in a manner that assures a timely market introduction.
• Participates in various product and process improvement activities to ensure products meet customer expectations.
• Participates in product, process and complaint related investigations to identify root causes of problems and then implements effective solutions.
• Ensures all such activities comply with CAPA system requirements.
• Provides manufacturing engineering expertise to resolve technical issues.
• Provides leadership to plan and executes process improvements.
• May perform other duties as assigned.
• Accountable for: a) The production of a portion of Abbott manufactured products to achieve a product availability level which meets customer expectations. b) Ensuring the achievement of department budget and supporting the achievement of other financial goals. b) Assuring that all operations are conducted in accordance with FDA, ISO and other applicable regulations, policies and procedures.
• Ensures CAPA and other complaince improvement activites are completed in a timely manner. d)Assisting with the achievement new product launch dates and key product and process improvement milestones. e) Training subordinates and ensuring that staffing requirements for all key positions are understood by management. f) Manages staff to ensure operations are conducted in a safe and compliant manner.

Qualifications:

- Bachelors degree in the physical sciences, engineering or business

- minimum of 5+ years of experience, in manufacturing related disciplines with companies engaged in the manufacture of FDA regulated products, including 2 years experience demonstrating leadership skills required to supervise processes and staff. Some previous exposure to resource planning, budgeting, employee development, materials management, inventory control is desired. Should have a prior record of achievement in areas relating to product availability, process improvement, or product quality.