About This Role
The Manufacturing Technician performs hands-on manufacturing, assembly, and production activities for Tetranite-based medical device products, ensuring compliance with company-approved work instructions and standard operating procedures (SOPs). This role supports all stages of production, from material staging to equipment operation and finished product handling.
Responsibilities
- Manufacture Tetranite-based products through all stages of production using company-issued work instructions and SOPs
- Set up, operate, and maintain manufacturing equipment in accordance with approved procedures
- Manage and maintain inventory of raw material supplies as well as WIP and finished goods parts for manufacturing per SOPs
- Perform in-process inspections and provide associated test documentation
- Accurately complete batch records, device history records (DHRs), and other manufacturing documentation in real time per Good Documentation Practices (GDP)
- Identify, document, and report manufacturing nonconformances and deviations to management and quality in a timely manner
- Perform routine calibrations, preventative maintenance (PM), and basic corrective maintenance (CM) on manufacturing equipment
- Support manufacturing process improvements and process validation activities
- Maintain a clean, organized, and compliant work area in accordance with cGMP and Good Documentation Practices (GDP)
- Participate in internal, external, and regulatory Agency audits and inspections
- Assist in the packaging, staging, and shipment of materials and finished products, including inventory tracking
- Maintain updated training records to SOPs per QMS
- Perform other manufacturing-related tasks as assigned
Requirements
- High school diploma or equivalent required; Associate's degree, technical/trade school certificate, or relevant manufacturing experience preferred
- Minimum one year of manufacturing or production experience, preferably within an FDA-regulated or ISO 13485-certified medical device company
- Working knowledge of MS Word and MS Excel
- Ability to read and follow detailed work instructions, SOPs, and batch records with a high degree of accuracy
- Demonstrated attention to detail and good manual dexterity for hands-on assembly and inspection tasks
- Ability to work on a standard on-site workday schedule, including cleanroom or controlled manufacturing environments as required
- Ability to work within ERP and eQMS systems as instructed
Nice to have:
- Current knowledge of, or ability to quickly learn, cGMP regulations and applicable industry standards (e.g., FDA 21 CFR Part 820, ISO 13485)
