Packaging Testing Technician II – Medical Device

About the role

The Packaging Testing Technician II supports the development, testing, and validation of medical device packaging systems to ensure product safety, sterility, and regulatory compliance. This hands‑on laboratory position works closely with packaging engineers, quality, manufacturing, and R&D teams.

Key responsibilities

• Perform package integrity tests such as dye penetration, bubble leak, burst, peel, and seal strength.
• Support packaging validation activities (IQ/OQ/PQ) and transportation simulation testing (vibration, compression, drop).
• Execute performance testing per ASTM, ISTA, and ISO standards and maintain accurate test records and reports.
• Operate, calibrate, and maintain packaging test equipment, ensuring routine checks and 5S lab cleanliness.
• Assist with change control, deviations, CAPAs, and supplier material evaluations.

Required profile

• Associate’s or technical degree in Packaging Science, Engineering, Biology, Chemistry, or related field.
• 4+ years of experience in a packaging, laboratory, or medical‑device environment.
• Strong attention to detail, documentation accuracy, and ability to follow test protocols precisely.

Required skills

• Hands‑on experience with package integrity testing methods (dye penetration, bubble leak, burst, peel, seal strength).
• Familiarity with ISO 11607, ASTM, ISTA, and FDA QSR (21 CFR 820) requirements.
• Statistical analysis tools for data evaluation.
• Equipment calibration and routine maintenance.