Medical Device Process Validation Engineer

Job Summary

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)