Machine Operator III - 3rd Shift

Machine Operator III- 3rd Shift

HOURS: Monday - Friday, 12:00 am - 7:30 am; plus OT as requested

Base rate plus shift differential of $1.25/hr.

Must be available to train on 1st shift for 2-3 weeks

Job Summary

The Machine Operator III is a highly skilled manufacturing professional responsible for operating, setting up, adjusting, and troubleshooting complex manufacturing equipment used to produce medical device components and products. This position independently performs advanced manufacturing processes in accordance with approved Manufacturing Work Instructions (MWIs), specifications, quality requirements, and company procedures.

The Machine Operator III serves as a technical resource within the production area and is expected to identify and resolve complex routine equipment and process issues, support process improvements, maintain high standards of product quality, and assist with training and mentoring less experienced operators. This position works closely with Production, Quality, Engineering, and Maintenance to support safe, efficient, and compliant manufacturing operations.

Essential Job Duties & Responsibilities

• Independently operate, set up, adjust, and monitor complex or specialized manufacturing equipment.
• Perform complex machine setups, changeovers, start-ups, adjustments, and process changes in accordance with approved procedures.
• Interpret and follow detailed MWIs, SOPs, specifications, drawings, process parameters, and other technical documentation.
• Monitor equipment and processes to ensure products consistently meet established quality and specification requirements.
• Perform detailed in-process inspections and measurements using calipers, micrometers, gauges, test equipment, microscopes, or other inspection tools as applicable.
• Identify, investigate, and troubleshoot complex routine equipment and process issues within the operator's level of authorization.
• Make authorized process or equipment adjustments to maintain product quality and production requirements.
• Recognize when issues require escalation to Maintenance, Engineering, Quality, or supervision and provide clear information regarding the issue and troubleshooting performed.
• Identify trends, recurring equipment problems, and process variations and communicate findings to appropriate departments.
• Accurately complete production records, electronic manufacturing records, inspection documentation, and other required quality documentation.
• Follow all applicable GMP, ISO 13485, quality system, safety, and product traceability requirements.
• Properly identify, segregate, and document nonconforming material or product.
• Perform operator-level equipment cleaning, inspection, maintenance, and preventive maintenance activities as applicable.
• Assist with equipment qualification, process validation, engineering builds, new product introduction, or process development activities as assigned.
• Serve as a technical resource to Machine Operators I and II.
• Train, mentor, and provide technical guidance to less experienced operators.
• Support continuous improvement, productivity, quality, scrap reduction, and process improvement initiatives.
• Maintain a clean, organized, and safe work environment.
• Communicate effectively with Production, Quality, Engineering, Maintenance, and other departments.
• Follow all company policies, procedures, PPE requirements, and controlled-environment/cleanroom requirements, as applicable.
• Perform other duties as assigned.

Education & Experience Requirements

• High school diploma or GED required.
• 3–5 years of manufacturing or machine operation experience, preferably in a medical device, pharmaceutical, or other regulated manufacturing environment.
• Must be able to read, write, and communicate effectively in English to understand and accurately execute MWIs, safety procedures, quality requirements, and other job-related documentation.
• Demonstrated proficiency operating and setting up complex manufacturing equipment.
• Demonstrated ability to troubleshoot routine and moderately complex equipment and process issues.
• Ability to independently perform machine setups, changeovers, adjustments, and process start-ups.
• Ability to read and interpret detailed MWIs, SOPs, specifications, drawings, and other technical documentation.
• Strong mechanical aptitude and problem-solving skills.
• Ability to accurately use precision measuring and inspection equipment.
• Strong understanding of product quality requirements and manufacturing processes.
• Ability to accurately complete production and quality documentation.
• Strong attention to detail and commitment to quality.
• Ability to work independently and make appropriate decisions within established procedures.
• Must be able to read, write, and communicate effectively in English to understand and accurately execute MWIs, safety procedures, quality requirements, and other job-related documentation.
• Ability to effectively train, mentor, and assist less experienced operators.
• Ability to work effectively with Production, Quality, Engineering, and Maintenance personnel.

Preferred Skills & Abilities

• Medical device, pharmaceutical, or other regulated manufacturing experience.
• Experience working under GMP and ISO 13485 requirements.
• Experience with CNC, molding, machining, automated equipment, precision assembly, or other specialized manufacturing processes, as applicable.
• Experience with complex machine setups and process adjustments.
• Experience using precision measurement equipment.
• Experience troubleshooting mechanical, electrical, pneumatic, hydraulic, or automated equipment, as applicable.
• Experience with process improvement, lean manufacturing, or continuous improvement.
• Experience supporting equipment qualification, validation, or new product introduction.
• Experience training or mentoring other employees.

Working Conditions

• Manufacturing/production environment.
• May work in a controlled environment or cleanroom, depending on the assigned production area.
• May be exposed to manufacturing equipment, noise, cleaning agents, and other typical production-area conditions.
• Required to follow applicable GMP, quality, safety, and cleanroom procedures.
• May require wearing appropriate personal protective equipment (PPE).
• Work may involve repetitive tasks and maintaining a consistent production pace.
• May be required to work overtime, weekends, or different shifts based on production needs

Physical Demands

This position requires the ability to stand and/or walk for extended periods and perform repetitive hand and arm movements associated with machine operation and material handling. Must have the manual dexterity and hand-eye coordination necessary to operate machinery, use hand tools and measuring equipment, and perform detailed visual inspections. The position may require frequent reaching, bending, stooping, grasping, and handling of materials and components, as well as the ability to lift, carry, push, or pull materials within the requirements of the specific position.

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We offer a full complement of benefits including health, dental, vision, life insurance, LTD/STD, 401(k) and generous PTO. Come work for a growing company that offers a fun, collaborative environment with work-family balance.

Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

EOE/Disabled/Veteran

Pay: $21.00 - $25.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Referral program
• Vision insurance

Work Location: In person