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.
• Create and qualify test methods, perform Gage Repeatability & Reproducibility (GR&R) studies, and document results in engineering studies, test protocols, reports, and validation documentation, including statistical analysis as required.
• Conduct root cause analysis for C&S process issues and evaluation findings, and communicate data-driven solutions and recommendations to R&D and cross-functional stakeholders.
• Support development and completion of associated risk management documentation (e.g., DFMEA, PFMEA, hazard analyses) by providing hands-on laboratory expertise and technical input.
• Support Design Reviews and Phase Exit Reviews by preparing required documentation, developing presentation materials, and presenting technical content related to cleaning, sterilization, and reprocessing.
• Partner with internal teams and external supplier resources (e.g., test laboratories, sterilization vendors) to ensure timely completion of product development and launch deliverables.
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