Job Title: Production Operator I
About Spineology
Spineology Inc. leads the way in ultra-minimally invasive spine surgery, revolutionizing how surgeons treat patients with spinal pathologies. Its proprietary technology, OptiMesh® is backed with IDE level data and sets the company apart from traditional fusion procedures enabling surgeons to optimize outcomes, while minimizing tissue disruption and enhancing patient recovery. With a strong commitment to patient-centered care, Spineology aspires to provide every spine patient the freedom from pain through the creation and delivery of ultra-MIS solutions.
Overview of Job Duties:
Operate production equipment, clean, assemble, and package medical devices in a Clean Room environment following all FDA, ISO, and Safety Regulations.
Responsibilities Include:
· Assemble and package medical devices according to standard operating procedures (SOPs) and assembly instructions in a cleanroom environment.
· Operate basic production equipment such as pouch sealers and printers.
· Perform quality inspections to ensure products meet regulatory standards (e.g., FDA, ISO 13485) and identify any defects.
· Assist in packaging, labeling, and preparing products for shipment to sterilization.
· Maintain a sterile and controlled cleanroom environment by following protocols for gowning, sanitation, and contamination prevention.
· Maintain accurate production records, batch logs, and electronic documentation systems.
Education/Experience:
· High school diploma or equivalent required.
· 0-2 years Medical Device, Pharma, or other regulated experience preferred.
Skills & Abilities:
· Ability to stand, walk, and sit for long periods of time within a Clean Room environment (controlled temperature and humidity).
· Dexterity in hands with fine motor skills for assembly operations.
· Basic computer skills for data entry.
· Strong attention to detail and ability to follow detailed instructions and standard operating procedures (SOPs).
· Ability to use basic measurement equipment (scales, rulers, etc.)
· Ability to read and write in English.
· Basic math skills (counting, addition, subtraction, multiplication, division with use of calculator).
· Ability to lift 25 pounds.
Compensation and Benefits
· Competitive salary commensurate with experience.
· Comprehensive health, dental, and vision insurance.
· Short-term/long-term disability and life insurance.
· Company paid holidays and generous paid time off .
· 401(k).
· Professional development opportunities.
Spineology is an equal opportunity employer committed to diversity and inclusion in the workplace.
Pay: $18.00 - $22.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Prescription drug insurance
- Vision insurance
Work Location: In person
