Under the direction of the Manufacturing Supervisor performs a variety of hand and machine-assisted operations on medical device assemblies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Performs a variety of machine and hand operations related to the manufacturing and assembly of medical devices including tending machines, loading and unloading fixtures and machines, hand operations such as deburring, buffing, mating components, visual in process inspection, other manual-skill functions, and trouble-shooting products and processes.
Maintains quality by inspecting parts during the assembly operation using measuring devices, gauges, and microscopes to ensure manufacturing consistency to required specifications.
Completes and maintains required production and quality control records and logs in accordance with Company production standards.
Changes setting on assembly equipment and adjusts machines during operations to maintain proper operating parameters and accuracy in accordance to specifications.
Provides feedback to co-workers, supervisor, and Company management on a regular basis to ensure efficient and effective assembly operations.
Cleans equipment and work area as necessary.
Actively participates and adheres to Company policies and programs on occupational health and safety, good manufacturing practices (GMP), and ISO procedures.
Demonstrates the ability to effectively and safely operate, and maintain assembly equipment used in the manufacturing processes.
EDUCATION and/or EXPERIENCE:
High School Diploma, GED, or equivalent work experience. Three months previous manufacturing assembly experience, or successful completion of the PMP Manufacturing Helper training module. Demonstrated ability to read, write, and speak English and read and interpret documents, instructions, engineering drawings, and procedure manuals. Demonstrated oral and written communications skills to effectively interface with all levels of Company management and staff. Demonstrated ability to perform basic mathematical functions including addition, subtraction, multiplication, division, percent, and ratios. Demonstrated reasoning ability to solve practical problems. Demonstrated ability to measure products.
LEVEL SPECIFIC MINIMUM REQUIREMENTS:
Must perform and sustain a performance level above 2.5 for the first 2 years average. Must annually be GMP qualified. Must also have successfully completed and passed SPC Training Level 1 and 2. Uses and understands the skills learned in SPC Training and demonstrates the use of SPC data during training others. This level will require assisting in developing work procedures relating to the nature of the job.
TRAINER REQUIREMENTS (if applicable):
Need to have completed PMP’s Train the Trainer program. Need to define what it takes to become a qualified trainer with proven effectiveness. Held accountable for the actions of the Learners until the Learners are released. Would assist in the development of the Learner testing. Needs to have knowledge in several areas.
LEAN QUALIFIED (if applicable):
Able to demonstrate lean flow capability. Must use lean initiatives in developing process improvements in assigned areas.
TQ LEADER (if applicable):
To qualify, the individual must have completed the TQ Leader training. Must also be an active team member of lean initiatives and have conducted a minimum number of TQ teams to progress to each level.
INSPECTOR OR MACHINE REPAIR (if applicable):
Make quality decisions on product through experience or setup/repair equipment. Full use of the arsenal of tools available – understanding AQL standards, Supplier quality agreements, Control plans, trained on the Inspection IPS’s, ability to read and interpret prints, full understanding and utilization of SPC and understanding of critical attributes of a customer’s product to maintain a certain quality level. Complete an electromechanical class or gone through a training period of 6 months focused on limited mechanical repairs on specific equipment.
REQUIRED LICENSES, CERTIFICATES, OR KNOWLEDGE:
Demonstrated ability to effectively and safely perform a minimum of five (5) assembly operations used in the manufacturing processes, as certified by Company training standards and productivity and quality performance records.
Regularly required to stand, walk, talk, and hear. Use of hands to touch, feel, or handle and reach with hands and arms. Occasionally required to sit, stoop, kneel, crouch, or crawl. Regularly required to lift and/or move up to 10 pounds and occasionally required to lift and/or move up to 50 pounds. Visual acuity required for close work, color differentiation, depth perception, and to adjust focus.
SAFETY HAZARDS OF THE JOB:
Manufacturing environment requiring appropriate eye protection. Frequent exposure to wet and/or humid conditions, moving mechanical parts, and fumes or airborne particles. Exposure to high noise level in the work environment requiring hearing protection. Limited exposure to vibration.
This job description does not list all the duties of the job. Employees may be asked by Company management to perform other duties. Performance evaluations, in part, will be based upon performance of the tasks listed in this job description.
Precision Medical Products has the right to revise this job description at any time. The job description is not a contract for employment. That is, employment with Precision Medical Products can be terminated with or without cause, and with or without notice at any time, at the option of the employee or that of the Company.