Medical Device Manufacturing Technician — Hands-on & Detail‑Oriented

RevBio, Inc.; Lowell (MA); On-site; USD 42,000 - 66,000; Full time

Benefits offered by this job

Dental insurance

Employee discounts

Health insurance

Paid time off

Vision insurance

Job summary

RevBio, Inc. in Lowell, MA, seeks a Manufacturing Technician to perform hands-on manufacturing, assembly, and production of Tetranite-based medical devices, following SOPs and work instructions.

You will support all stages of production, including material staging, equipment setup, in-process inspection, and real-time documentation in ERP and eQMS. The role emphasizes GDP, batch records, DHRs, calibration, and maintenance, with collaboration across QA, R&D, and cross-functional teams to drive

Qualifications

• High school diploma or equivalent required.
• Associate's degree, technical/trade certificate, or manufacturing experience preferred.
• Minimum one year of manufacturing or production experience in FDA-regulated or ISO 13485 environment preferred.

Responsibilities

• Manufacture Tetranite-based products through all stages of production using SOPs and work instructions.
• Set up, operate, and maintain manufacturing equipment per approved procedures.
• Manage and maintain inventory of raw materials, WIP and finished goods per SOPs.
• Perform in-process inspections and provide test documentation.
• Complete batch records and device history records (DHRs) in real time per GDP.
• Identify, document, and report manufacturing nonconformances and deviations to management and quality.
• Perform routine calibrations and preventive/corrective maintenance on equipment.
• Support manufacturing process improvements and process validation activities.
• Maintain a clean, organized, and compliant work area per cGMP and GDP.
• Participate in internal, external, and regulatory audits and inspections.
• Assist in 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.

Skills

SOP literacy

Manual dexterity

GDP knowledge

MS Excel

ERP/eQMS usage

Education

High school diploma

Associate degree preferred

Tools

ERP

eQMS

Job description

RevBio, Inc. in Lowell, MA, seeks a Manufacturing Technician to perform hands-on manufacturing, assembly, and production of Tetranite-based medical devices, following SOPs and work instructions.

You will support all stages of production, including material staging, equipment setup, in-process inspection, and real-time documentation in ERP and eQMS. The role emphasizes GDP, batch records, DHRs, calibration, and maintenance, with collaboration across QA, R&D, and cross-functional teams to drive