Responsibilities may include the following. Other duties may be assigned. Performs functions directly related to physical processing of musculoskeletal tissues, traditional tissues, or proprietary products for surgical implantation. Prepares and maintains all materials, supplies, and equipment for all aspects of operations.
* Read, understand, and follow Standard Operating Procedures (SOP's). * Complete one-week exposure in 100K room (includes- competencies in gowning requirements, general cleaning, biohazards waste handling, operation of autoclaves and bottle washer. * Read and understand routers, work orders, and/or basic blueprint specifications. * Accurately completes all paperwork in accordance with FDA, ISO, and all company procedures and policies. * Monitor sterility of self, supplies, tissue, and environment as directed. * Aseptically process tissue to specifications and requirements while maintaining sterility of the clean room and/or isolators. * Transfer donor tissue and/or supplies into the core and/or isolators. Aseptically transfer processed tissues to next operation or assigned quarantine locations. * Correctly determine bio-hazardous waste from garbage. Safely remove trash and biohazard waste per procedures. * Perform quality checks on the processed tissues and paperwork prior to release to next operation. * Stock supplies as needed within the processing area. * Maintain equipment in good working order and document problems for submission to the maintenance department. * Set-up and breakdown processing room(s) as required.
BASIC QUALIFICATIONS
* A minimum of a HS diploma or equivalent. * Understanding and practice in principles of aseptic techniques and universal precautions
PREFERRED QUALIFICATIONS * Computer skills knowledge must include basic data entry, completing forms, and locating and opening documents needed to complete tasks as assigned.
* Life Sciences or Technical Degree. * A minimum of 2 years' experience in tissue banking, surgical technician, nursing, or production experience in a sterile environment with a pharmaceutical or medical device company preferred.
PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must be able to stand for long periods of time and work for up to four hours without a rest break in an aseptic environment. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job involve normal vision
In this position, a skilled trade mechanic installs, maintains, and repairs manufacturing equipment, physical structures, piping systems and electrical systems, consistent with trade level skills associated with light industry.
* Visually inspect, troubleshoot, repair, and perform preventive maintenance for machinery, process systems, facility equipment and production equipment. * Routinely monitor machines or equipment to detect malfunctions and discusses machine operation variations with supervisors or other maintenance workers to diagnose problem or repair machine. * Maintain equipment following approved preventive maintenance procedures and through routine inspections. Assist in the development of predictive maintenance activities. * Diagnose equipment failures using calibrated meters, thermometers and any other pertinent test equipment * Make equipment repairs using hand tools, power tools and any meters or gauges required to bring equipment back into operational specification * Dismantle and/or rebuild defective machines and equipment, and installs new or repaired parts. * Clean and lubricates shafts, bearings, gears, and other parts of machinery. * Install and repair electrical and electronic components of machinery and equipment. Install and repair automated machinery. Will have a working knowledge of programmable logic controllers. * Assemble, install, and maintain piping systems and related steam, hydraulic and pneumatic equipment. Repair and/or replace gauges, valves, pressure regulators, pumps and related equipment. * Repair and maintain physical structure of establishment. * Set up and operate machine tools such as lathe, grinder, drill, and milling machine to repair or fabricate machine parts, jigs and fixtures, and tools. * Able to be trained to operate welding equipment to cut or join metal parts. * Will develop a good working knowledge of the building management system used to monitor equipment and areas critical to process operations. * Participation in the on-call rotation. * Complete aseptic training and be qualified to enter the sterile processing areas. * Other duties as assigned.
QUALIFICATIONS Adhere to the Medtronic Core Behaviors of Customer Focus, Candor, Trust and Respect, Courage, Accountability, and Passion to Win.
* Should possess a strong knowledge in various mechanical systems and be able to apply that knowledge to plant systems and production equipment. * Trade knowledge and experience with basic 110 volt electrical systems, such as transformers and wiring, and electrical and electronic components of machinery and equipment. * Trade knowledge and experience with basic piping and plumbing systems. * Should have an understanding of common computer programs. * Will be proficient in a trade discipline such as refrigeration, electric, process controls, etc. * The ability to interact professionally with other departments. * Have a sense of urgency and the drive to get the job accomplished with minimal equipment Downtime. * Must be able to work alone and complete assigned tasks with minimal supervision.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job involve normal vision. The noise level in the work environment is usually moderate to loud.
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