Operator I-mr - Axelon Services Corporation

Job Description:

This is a non-exempt position responsible for the production of high-quality medical devices within a manufacturing cell. The role involves performing assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and other related medical device assemblies. Tasks are performed under close supervision following specified and standardized procedures.

Key Responsibilities:

• Perform assembly, repair, and testing of medical devices (e.g., pacemakers, ICDs) according to standardized procedures.
• Ensure accurate and up-to-date documentation for cell operations and functions.
• Maintain positive and professional communication with internal and external customers, including during facility tours.
• Follow all safety guidelines, including the proper use of safety devices during operations.
• Participate in continuous improvement initiatives aimed at enhancing production processes and meeting quality and profitability metrics.
• Maintain accurate records, ensuring that all parts are traceable and quality issues are addressed.
• Demonstrate a basic understanding of Lean Manufacturing principles.
• Work with the Manufacturing Supervisor/Manager to set and monitor individual and cell performance metrics.
• Support Divisional initiatives, Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Qualifications:

• Ability to read, comprehend, and follow written procedures; understand and follow verbal instructions.
• Knowledge of and ability to use electronic data collection systems and computer software packages.
• Ability to prioritize tasks based on precedence and importance.
• Strong dexterity to handle and maneuver small components and parts.
• Critical decision-making skills with minimal supervision.
• High school diploma or equivalent preferred.

Dress Code Requirements for Production Area:

• Clothing must be non-shedding and free of frayed hems or loose threads. No tassels, fringes, glitter, or sequins allowed.
• Clean and free from visible contamination (sand, mud, dirt, lint, etc.).
• Upper body clothing must fit under the lab coat/gown; no turtlenecks or high-necked clothing protruding above the neck of the lab coat/gown.
• Sleeves must not extend beyond the cuff of the lab coat/gown.
• No caps, hats, scarves, or bandanas under the bouffant. Head wraps must be covered with the bouffant and fully covered by the lab coat/gown.
• Loose-fitting clothing is not permitted near machinery or soldering/brazing torches.
• Shoes must be worn at all times in the production area, with stockings or socks required. Heels must not be higher than 2 inches. Open-toe, open-heel shoes, sandals, clogs, slippers, or shoes with straps or visible toes are not allowed.
• Changing shoes in the production area is not permitted except in designated gowning rooms.
• Torsos, upper arms, and legs must be covered. Short skirts, pants, and sleeveless tops are not allowed. Full-length stockings, leggings, or pants must be worn under ankle-length skirts.
• No nail polish, acrylic nails, or similar coatings are permitted. Jewelry or body piercings that could pierce gloves or cannot be covered under gowning materials are not allowed.
• Makeup is prohibited, but lip balm in stick form is acceptable if applied outside the production area and before hand washing.
• Scented products are not permitted except deodorant. Lotions are not allowed after hand washing.
• Cover any open or bleeding wounds with a bandage.
• Ensure that personal appearance is in compliance with workplace standards.