Position Overview
Must-Haves:
Cleaning & Sterilization Validation, Test Method Development, product quality, DFMEA
Job summary:
Mechanical Product Validation Engineer with hands-on expertise in cleaning, sterilization, and reprocessing validation for reusable medical devices. Experienced in developing test methods, executing C&S feasibility and validation studies, conducting GR&R and root cause analysis, and supporting risk management and design reviews through cross-functional collaboration.
Responsibilities:
• Develop soiling, cleaning, and extraction processes for reusable scopes and instruments, and accessories (I&A), incorporating real-world use conditions and cleanability considerations.
• Plan, execute, and analyze Cleaning and Sterilization (C&S) feasibility studies, cleanability assessments, and sterilization validations for reusable scopes and I&A.