Operator I

This position is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies.

Key Responsibilities:

• Perform routine assembly, repair, and testing operations according to specified and standardized procedures.
• Work under close supervision with all work being continually reviewed for quality and accuracy.
• Ensure relevant job documentation for cell operations and functions is accurate, complete, and up to date.
• Clearly communicate ideas, problems, and solutions to all levels of manufacturing management in both written and verbal formats.
• Maintain a positive and professional attitude when interacting with internal and external customers, including facility tours.
• Follow all safety guidelines and utilize appropriate safety devices during operations.
• Participate in continuous improvement and quality initiatives to enhance production processes and achieve quality and profitability goals.
• Maintain accurate production records, traveler documents, and quality documentation to ensure traceability of all parts and products.
• Support investigations and resolution of quality issues to ensure product integrity.
• Demonstrate a basic understanding of Lean Manufacturing principles.
• Participate with Manufacturing Supervisors and Managers in setting and monitoring individual and cell performance goals and metrics.
• Support divisional initiatives and comply with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Required Skills and Qualifications:

• Ability to read, understand, and follow written procedures and verbal instructions.
• Ability to utilize electronic data collection systems and computer software applications.
• Strong organizational skills with the ability to prioritize work based on timing, importance, and production requirements.
• Ability to handle and maneuver small components and parts with precision.
• Ability to make sound decisions and judgments with minimal supervision.
• High School Diploma or equivalent preferred.

Manufacturing Environment Requirements:

• Must adhere to strict cleanroom and gowning requirements.
• Clothing must be non-shedding, clean, and free of loose fibers, frayed hems, glitter, sequins, or other detachable materials.
• Loose knit garments, fleece, sweaters, and similar materials are not permitted.
• Clothing must fit completely under required lab coats or gowns.
• Appropriate closed-toe, closed-heel footwear is required at all times.
• Sandals, clogs, slippers, open-toe shoes, and open-heel shoes are prohibited.
• Makeup, nail polish, artificial nails, and scented personal products are not permitted in production areas.
• Jewelry and body piercings that may compromise gowning or gloves are prohibited.
• Any open wounds must be properly covered with bandages.