Operator I

Medical Device Production Specialist

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.

Performs routine assignments according to specified and/or standardized procedures. Work is closely and continually reviewed.

Key Responsibilities

• Ensure relevant job documentation for cell operations and functions is accurate and up to date.
• Clearly communicate ideas, problems, and solutions to all levels of manufacturing management in both written and oral form.
• Maintain a positive attitude when interacting with internal and external customers.
• Follow safety guidelines and utilize appropriate safety devices when performing all operations.
• Participate in continuous improvement and quality initiatives to enhance production processes and achieve quality and profitability metrics.
• Maintain accurate records to ensure traveler and quality documents are accurate, all parts are traceable, and quality issues can be addressed.
• Demonstrate a basic understanding of Lean Manufacturing.
• Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics.
• Support divisional initiatives and Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Required Qualifications

• Ability to read, comprehend, and follow written procedures.
• Ability to understand and follow verbal instructions.
• Ability to utilize electronic data collection systems and computer software packages.
• Ability to prioritize work based on precedence and importance.
• Ability to handle and maneuver small components and parts.
• Ability to make critical decisions and judgments with minimal supervision.
• High school diploma or equivalent required.

Production Area Dress & Safety Requirements

• Clothing must be non-shedding and free of frayed hems or loose threads.
• No tassels, fringes, glitter, sequins, or other items that could become dislodged.
• Sweaters, sweater vests, loose-fiber garments, loose-knit clothing, and fleece are not permitted.
• Clothing must be clean and free of visible contamination.
• Clothing must fit properly under the required lab coat/gown.
• Sleeves must not extend beyond the cuff of the lab coat/gown.
• Caps, hats, scarves, or bandanas must not be worn under the bouffant.
• Loose-fitting clothing is not permitted around machinery or soldering/brazing torches.
• Shoes must be worn at all times in the production area.
• Stockings or socks are required.
• Sandals, clogs, slippers, open-toe, or open-heel shoes are not permitted.
• Torsos, upper arms, and legs must be covered.
• Nail polish, acrylic, artificial nails, or similar nail coatings are not allowed.
• Jewelry or body piercings that cannot be covered under gowning materials are not allowed.
• Makeup is not permitted.
• Scented personal-use products are not permitted, except deodorant.
• Any open or bleeding wound must be covered with a bandage.
• Clothing and personal items must not create a safety concern or be offensive.