Medical Device Process Validation Engineer

A company is looking for a Remote Medical Device Process Validation Engineer. Key Responsibilities Review process validations to identify gaps in internal and external requirements Identify process validation needs and generate test method validation and process validation protocols Generate quality outputs for Design History File documents and meet designated deadlines Required Qualifications Bachelor's Degree in Mechanical, Biomedical, or Chemical Engineering Up to one year of post-educational experience in medical device manufacturing Understanding of medical device regulations and best practices Proficiency in statistical, quality, and continuous improvement methods and tools Knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971)