Job Summary: The effective management of Inogen's manufacturing associates, processes and materials to produce the expected results in Quality and Output of FDA registered medical devices. Instill and maintain a sense of pride and ownership within the manufacturing organization that will continuously compel the team to produce and deliver high quality products on time and on budget. Drive continuous improvement efforts to identify and eliminate waste, reduce cost and improve quality. Establish and supervise procedures within the organization that comply with FDA, ISO and OSHA standards.
Responsibilities (Specific tasks, duties, essential functions of the job)
Direct the handling of materials from receipt thru shipment. Accept responsibility for shipping only highly reliable product. Adjust Manufacturing Associates' priorities and daily goals to meet changing demands. Identify Manufacturing Associates' strengths and weaknesses and adjust responsibilities and training requirements appropriately. Determine personnel performance, create requisitions for hiring, Performance Improvement Plans (PIPs) when necessary, promotion opportunities and be involved in the interviewing, hiring and if necessary termination of Associates. Approve and initiate changes to production, packaging and shipping procedures in accordance with ISO and FDA standards. Review metrics as part of the continuous improvement program. Administer and document regular training of production personnel. Provide oversight to the production control and inventory control activities. Work closely with Engineering, Materials and Quality to drive continuous improvement activities throughout manufacturing. Work with the Materials group to identify and address material and supplier issues. Responsible for all inventory accuracy, including R/I, MRB, FG, stockroom and WIP. Responsible for ensuring production cells have materials required to meet production goals. Communicates delivery and reorder trigger points to the Materials group. Performs transactions moving materials from location to location or from location to accounts. Performs and reconciles inventory cycle counts on a weekly basis. Effectively manages floor stock, oversized and 2 bin system materials. Supports kanban inventory procedures. Assists in the material planning process. Participates in the MRB process to keep material accurate and flowing through disposition. Oversees inventory audits. Works closely with Quality to ensure only release material is placed into inventory and delivered to the production floor. Maintain all production personnel training records and verify the training records contain all documentation needed to support the individual's qualifications of a given assembly or test station. Maintain the Training Matrix used to track individual training progression and provide a snapshot of individual qualifications. Work closely with Document Control to track and distribute deviations issued to the production floor as well as all Manufacturing Procedures and Quality Procedures. Confirm that only the most current procedures are released and on the floor. Coordinate with Product Development to transfer new products/line extensions from the development stage to production release while assuring changes are designed properly for test and manufacturing. Analyze improvements, revisions and implementation of new business processes or systems. Maintain regular and punctual attendance. Comply with all company policies and procedures. Assist with any other duties as assigned. Operations Supervisor III – Direct supervision for no more than 7 Leads. May be called upon to represent the Director of Manufacturing in company meetings.
Knowledge, Skills, and Abilities Excellent management skills, both of individuals as well as projects. Must have strong work ethic. Excellent oral and written communication skills required. Understanding of inventor control. Attention to detail is required. Analytical & problem-solving skills & ability to multi task. Solutions-oriented problem solver. Excellent planning, communication and organizational skills. Ability to effectively interface with different departments within the company. Qualifications (Experience and Education)
Associates degree in Mechanical, Electrical, Systems Engineering, or related technical discipline, required. 5 years of experience in a manufacturing environment, required. Preferably in medical device manufacturing, required. 1-2 years' in a lead or supervisory role, required. Intermediate knowledge/proficiency Microsoft Office and data base systems, required. A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.
