Operator I - Machine Operator

Position Overview:

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

Key Responsibilities:

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

  
  
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  Ensure that relevant job documentation for cell operations and functions is accurate and up to date.

  
  
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  Clearly communicate ideas, problems, and solutions to all levels of manufacturing management in both written and oral form.

  
  
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  Maintain a positive attitude when interacting with internal customers and external customers such as tours.

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

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

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

  
  
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  Demonstrate a basic understanding of Lean Manufacturing.

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

  
  
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  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.

  
  
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  Read, comprehend, and follow written procedures; understand and follow verbal instructions.

  
  
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  Utilize electronic data collection systems and computer software packages.

  
  
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  Prioritize work by determining the sequencing and timing of different jobs based on precedence and importance.

  
  
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  Handle and maneuver small components and parts.

  
  
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  Make critical decisions and judgments with minimal supervision.

  
  

Qualifications:

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  High school degree or equivalent required.

  
  

Dress Code Requirements for Tour and On-the-Job:

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  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.

  
  
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  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.

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

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

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

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

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

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

  
  
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  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, be clean, and laundered.

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

  
  
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  Shoes must be worn at all times in the production area. Stockings or socks are required.

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

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

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

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

  
  
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  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.

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

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

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

  
  
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  Makeup shall not be worn.

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

  
  
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  Scented personal use products shall not be worn, except deodorant. Lotions shall not be applied after hand washing.

  
  
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  Cover any open or bleeding wound with a bandage.

  
  
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  Don't wear anything that could be offensive.