Communication Skills, Computer Software, Continuous Improvement, Customer Relations, Data Collection, Defibrillator, Documentation, Environmental Management Systems, Establish Priorities, Healthcare Quality, Housekeeping/Cleaning, Implants, Lean Manufacturing, Manufacturing, Manufacturing Management, Medical Equipment, Pacemaker, Performance Metrics, Problem Solving Skills, Profit & Loss, Quality Assurance, Quality Management, Quality Metrics, Record Keeping, Regulatory Requirements
Job Title: Operator
Location: Plymouth, MN
Duration: 12 Months with Possible Extension
Position Summary
This position is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, the Operator 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 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 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 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 and Qualifications
- Ability to read, comprehend, and follow written procedures and 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.
- High school degree or equivalent preferred.
Dress Code Requirements (Interview Tours and On-the-Job)
- 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 the fabric tightly with your 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 extend beyond the cuff of the lab coat/gown.
- 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.
- The tail end of the scarf must be fully covered by the lab coat/gown.
- Must be made of tightly woven fabric, be clean, and properly laundered.
- Loose-fitting clothing shall not be worn around machinery or soldering/brazing torches.
Footwear Requirements
- Shoes must be worn at all times in the production area.
- Stockings or socks are required.
- Shoe heels 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 weaves where toes can be seen are not allowed.
- Changing shoes in the production area, other than in a gowning room, is not allowed.
Clothing Coverage Requirements
- 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.
- Ankle-length skirts are permitted; however, full-length stockings, leggings, or pants must be worn underneath.
Personal Appearance Requirements
- 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 permitted in the production area.
- Makeup shall not be worn.
- Lip balm in stick form is acceptable when applied outside 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.
- Any open or bleeding wound must be covered with a bandage.
- Do not wear anything that could be considered offensive