Operator I

Overview:
This position is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, this role 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.

• Ensure that 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 (including tours).

• Follow safety guidelines and utilize appropriate safety devices when performing all operations.

• Participate in continuous improvement/quality initiatives to enhance production processes and achieve quality and profitability metrics.

• Maintain accurate records to ensure traveler and quality documents are complete, all parts are traceable, and quality issues can be addressed to assure the quality of all products.

• Demonstrate a basic understanding of Lean Manufacturing.

• Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics to continuously improve operations.

• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• High school degree or equivalent required.

• Ability to read, comprehend, and follow written procedures; understand and follow verbal instructions.

• Understanding of and ability to utilize electronic data collection systems and computer software packages.

• Ability to prioritize work by determining sequencing and timing of different jobs based on precedence and importance.

• Ability to handle and maneuver small components and parts.

• Ability to make critical decisions and judgments with minimal supervision.

General Guidelines:

• Clothing must be non-shedding and free of frayed hems or loose threads.

• Tassels, fringes, glitter, sequins (sewn or glued on), and any other items that could become dislodged are not allowed on clothing.

• To verify a fabric can be worn: pull at the fabric tightly with fingers-if fibers are dislodged, the garment may not be worn in the production area.

• Sweaters, sweater vests, loose fiber garments, loose knit, or fleece may not be worn.

• All clothing must be clean and free of visible contamination (sand, mud, dirt, lint, etc.).

• All clothing, from the waist up, must fit under the lab coat/gown.

• Turtlenecks or high-necked clothing shall not stick out above the neck of the lab coat/gown.

• Sleeves shall not stick out beyond the cuff of the lab coat/gown.

Headwear:

• Caps, hats, scarves, or bandanas shall not be worn under the bouffant.

• Head wraps/scarves worn to accommodate customs:

  • Must be covered with the bouffant, and the tail end of the scarf must be fully covered by the lab coat/gown.

  • Must be of tightly woven fabric, clean, and laundered.

Footwear:

• Shoes must be worn at all times in the production area.

• Stockings or socks are required.

• The heel of a shoe must not be pointed or higher than 2 inches.

• Sandals, clogs, slippers, open toe, or open heel shoes are not allowed.

• Shoes with straps or weave where toes can be seen are not allowed.

• Changing shoes in the production area, other than a gowning room, is not allowed.

Clothing Fit:

• Loose-fitting clothing shall not be worn around machinery or soldering/brazing torches.

• Torsos, upper arms, and legs must be covered.

• Pants above the ankle, skirts above the ankle, skirts with slits, short shirts (above the navel), and sleeveless tops are not allowed.

• Skirts at the ankle are allowed, but full-length stockings, leggings, or pants must be worn underneath.

Personal Appearance:

• Nail polish, acrylic, artificial nails, or similar nail coatings are not allowed.

• Jewelry or body piercings that can pierce gloves or cannot be covered under gowning materials will not be allowed in the production area.

• Makeup shall not be worn.

• Lip balm in stick form is acceptable when applied outside of production areas and prior to hand washing.

• Scented personal use products shall not be worn, except deodorant.

• Lotions shall not be applied after hand washing.

• Cover any open or bleeding wound with a bandage.

• Do not wear anything that could be offensive.