Operator I_MN ONLY

Manufacturing Cell Operator (Medical Devices)

Location: Plymouth, MN 55442 Shift: 5am to 3:30pm

Position Summary: 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 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 customers and external customers such as 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 accurate, 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 that continuously seek to improve the quality of 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.

Required Skills & Abilities:

• 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 the 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.

Education:

High school degree or equivalent preferred.

DRESS CODE REQUIREMENTS (for interview and on-the-job): Note: These requirements are mandatory.

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

Prohibited on Clothing:

• Tassels, fringes, glitter, sequins (sewn or glued on), or any items that could become dislodged.
• To verify fabric: pull at the fabric tightly with fingers. If fibers are dislodged, the garment may not be worn.
• Sweaters, sweater vests, loose fiber garments, loose knit, or fleece.

General Cleanliness:

• All clothing must be clean and free of visible contamination (sand, mud, dirt, lint, etc.).
• Fit Under Lab Coat/Gown (from waist up): All clothing from the waist up must fit under the lab coat/gown.
• Turtle necks 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, be clean, and laundered.

Footwear (worn at all times in production area):

• Stockings or socks are required.
• Heel must not be pointed or higher than 2 inches.
• Not allowed: Sandals, clogs, slippers, open toe, open heel, or shoes with straps/weave where toes can be seen.

Body Coverage:

• Torsos, upper arms, and legs must be covered.
• Not allowed: Pants above the ankle, skirts above the ankle, skirts with slits, short shirts (above the navel), sleeveless tops.
• Skirts at the ankle are allowed, but full-length stockings, leggings, or pants must be worn under them.

Personal Appearance & Hygiene:

• 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 are not allowed.
• Makeup shall not be worn. Lip balm in stick form is acceptable, only 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.
• Open or bleeding wounds must be covered with a bandage.
• Do not wear anything that could be offensive.
• Loose Fitting Clothing: Shall not be worn around machinery or soldering/brazing torches.