Job Scope• Assume principal ownership of defined Manufacturing sections and/or product lines with responsibility for supervising associated manufacturing staff of moderate to high span of control and/or skill level.
• Delivering manufacturing requirements according to production schedules for those products including manufacturing requirements for support of new product integration, process development, equipment validations, and process validations.
• Leads and engages production team employees, plans, coordinates, and supervises the daily activities of their assigned Manufacturing section and/or product lines to ensure efficient production. Setting the daily schedule, priorities, and task delegation and managing resources to execute the production schedule.
• Manufacturing environment is a high complexity, small/large run production environment. Responsible for standard and custom Luminex instrument product lines manufactured in an environment that is ISO certified and includes products that are FDA regulated.
Duties and Responsibilites - Coordinate (developing and implementation) the daily work schedule, priorities, and task delegation within a work section
- Supervise associated manufacturing personnel
- Establish, execute and maintain appropriate role-specific training plans; ensure that each team member is properly trained on systems, processes and equipment.
- Deliver manufacturing requirements and attainment of production schedule for responsible Manufacturing section and/or product lines, qualification/processing of incoming materials, production intermediates, and stability samples
- Deliver timely completion of manufacturing sections of process documentation and related business system transactions
- Oversee section cycle counts; deliver timely completion of cycle counts and physical inventory
- May oversee specific calibration and maintenance of manufacturing equipment and infrastructure.
- Document non-conformances and participate in Material Review Board.
- Participates in the integration of new products and processes into the Manufacturing organization; participates in validation and integration of new products and processes; participates in design transfer teams as required
- Identify process improvements to improve quality and efficiency. Participate in sustaining projects for improvement of manufacturing processes, cleaning processes, product specifications, process/test equipment/fixtures, analysis tools, and business systems
- Participate in/execute equipment and process validations
- Participate in or lead investigations and resolution of findings impacting the Instrument Manufacturing Organization identified through audits, non-conformances, corrective/preventive actions, or customer complaints escalation
- Develop and/or updates of work instructions for new and/or improved processes
- Maintain cleanliness and integrity of manufacturing and storage areas
- Lead and/or participate in departmental and interdepartmental training; maintain current training to standard operating procedures per matrix, work instructions, and applicable changes affecting the Manufacturing departmental training compliance
- Interface with other departments as required; represents the department on internal committees and project teams as assigned.
- Maintain personal compliance and facilitate departmental compliance with the Quality Management System.
- Adhere to safety, disposal, and/or gowning requirements; facilitate departmental compliance
- Perform change control review as required to support change requirements including Engineering Change Orders, Document Change Control, and Deviations. Take ownership of section task-specific and change control training
- Drive document change control and basic engineering change control activities specific to Manufacturing section and/or product lines.
- May manage Manufacturing section and/or product line specific labor routings and lead times for optimal accuracy; facilitate definition of labor routings and lead times for new product introductions.
Education, Experience and Qualifications- Associate's Degree Associates of Science degree in the field of Engineering/Engineering Technology or related field degree with equivalent amount of experience required or
- Bachelor's Degree Bachelor of Science degree in the field of Engineering/Engineering Technology or related field preferred
- 5+ Years Relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization with a Bachelor's Degree preferred
- 8+ Years Relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization with an Associate Degree required
- 2+ Years Relevant Manufacturing Operations leadership experience required
Training and Skills- Mathematics aptitude (High proficiency)
- Knowledge of Electro-Mechanical Assembly (High proficiency)
- Statistical aptitude (Low proficiency)
- Knowledge of clean manufacturing environments (Low proficiency)
- ISO 13485 and FDA Quality System knowledge (Medium proficiency)
- Proficiency in use of process based Manufacturing Resource Planning systems such as Oracle or SAP (Medium proficiency)
Standard Working Conditions- Second and swing shift coverage may be required - Occasionally
Travel Requirements- 10% Limited travel may be required
