Engineering Contractor

Job Title: Engineering Contractor - Product Release & Validation Location: On-site / Hybrid (as required) Summary: We are seeking an experienced Engineering Contractor with a minimum of 3 years in a regulated medical device environment. The role will support compliant product release activities with a focus on documentation, validation, sterile barrier systems, and packaging processes. This is a hands-on position working closely with cross-functional teams to ensure products meet regulatory and quality standards. Required Skills: Strong understanding of FDA QSR and ISO 13485 compliance Experience authoring, executing, and reviewing validation documentation (IQ/OQ/PQ) Knowledge of sterile barrier system testing: seal strength, integrity, performance Hands-on experience with controlled documentation, protocols, reports, and change records Understanding of ASTM packaging validation standards (ASTM F88/F88M, F1929, F2096, F1980) Familiarity with thermoforming and package sealing processes (preferred) Experience supporting packaging process validation and product release activities Qualification: Bachelor's degree in Engineering or related field Minimum 3 years' experience in a regulated medical device environment Strong validation and documentation background

Created: 2026-03-10