• Perform equipment setup, operation, repair, and scheduled critical preventative maintenance tasks to meet all standards for safety, quality and efficiency. These tasks must be completed under minimal supervision.
• Maintain machine raw material feeds, perform any fault clearing and clear stoppages on automated equipment.
• Utilize human machine interfaces (HMIs) to identify and correct shifts in process control.
• Ensures adequate raw material is prepared correctly and jobs are run in a timely manner to ensure on-time delivery.
• Executes equipment inspections and generates emergency, corrective, or preventative work orders as needed.
• Troubleshoot and identify potential solutions for mechanical errors, safety issues or general operating inefficiencies within the production processes.
• Interface directly with cross-functional departments to help drive preventative maintenance schedules, techniques, and training improvements.
• Able to utilize computer systems to support in the material inventory and quality management processes.
• Participates in manufacturing processes to support new product design transfer and process development.
• Investigates and resolves process issues within their equipment cells.
• Execution of equipment/process validation protocols under minimal supervision.
• Perform routine cleaning/inspection/lubrication of machinery.
• Performing maintenance and calibration of measuring and monitoring devices.
• Able to use measuring tools to ensure correct tolerances.
• Works from specifications, work orders, and general instructions from Production Supervisor/Team Lead.
• Able to write and/or revise production work instructions, preventative maintenance tasks, and equipment documentation.
• Safely follow standard operating procedures including but not limited to material handling, record keeping, packaging, and shipment preparation. Must follow all Good Manufacturing Practices (GMPs).
• Notifies Team Leader or Production Supervisor of any discrepancies to ensure quality standards and safety of operations are maintained at all times.
• Excellent attention to detail, good organization, and capable of working independently with minimal instruction from production supervisor.
• Able to work in small groups and cross functional teams to troubleshoot issues, identify and implement collective corrective actions.
• Maintain a clean work environment suitable for medical device manufacturing and cleanroom production.
• Train and mentor fellow technicians on the manufacturing processes, equipment, and general mechanical skills.
• Performs other duties as required
Education and Experience:
• High school Diploma and at least 3 years of on-the-job manufacturing experience.
Preferred Skills and Competencies:
• Experience running, debugging, and/or maintaining highly automated equipment.
• Experience working with Human Machine Interfaces (HMIs).
• Experience working with discrete component assembly
• Familiarity with manufacturing instrumentation such as optical gauging, video microscopes, micrometers, calipers, feeler gauges, dial indicators, and gauge blocks.
• Self-starter capable of dealing with a variety of tasks in a fast paced, multi-tasking environment.
• Must be proficient in English language to be able to read documentation, communicate, and write.
• Ideal candidate will have keen eye for quality, is dependable, and will work collaboratively within a team, and possess a positive attitude.
• Manufacturing experience in Medical Device Industry.
• Previous experience working in a clean room environment.
• Previous experience with assembling, debugging and optimizing discrete component assembly processes.
• Previous experience with technologies such as laser welding, heat staking, ultrasonic welding, and ESD-sensitive devices.
• Familiarity with machining equipment and processes such as milling machines, lathes and grinders.
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