Mechanical Product Validation Engineer

Role: Mechanical Product Validation Engineer Important Update from Hiring Manager Looking specifically for a Mechanical Engineer Candidate must possess a Bachelor’s or Master’s degree in Mechanical Engineering Required Skills Test Method Development Product Quality

DFMEA

Medical Device Validation Job Summary Seeking an experienced Mechanical Product Validation Engineer with strong hands‑on expertise in cleaning, sterilization, and reprocessing validation for reusable medical devices. The ideal candidate will have experience in developing test methods, executing cleaning & sterilization feasibility and validation studies, conducting GR&R and root cause analysis, and supporting risk management and design reviews through cross‑functional collaboration. Key Responsibilities Develop soiling, cleaning, and extraction processes for reusable scopes, instruments, and accessories while incorporating real-world usage conditions and cleanability considerations. Plan, execute, and analyze Cleaning & Sterilization (C&S) feasibility studies, cleanability assessments, and sterilization validations for reusable scopes and instruments & accessories (I&A). Create and qualify test methods, perform Gage Repeatability & Reproducibility (GR&R) studies, and document results through engineering studies, test protocols, reports, and validation documentation including statistical analysis. Conduct root cause analysis for C&S process issues and evaluation findings; provide data‑driven recommendations and solutions to R&D and cross‑functional stakeholders. Support development and completion of risk management documentation including DFMEA, PFMEA, and hazard analyses by providing laboratory expertise and technical inputs. Participate in Design Reviews and Phase Exit Reviews by preparing technical documentation, presentation materials, and presenting validation and reprocessing‑related findings. Collaborate with internal engineering teams and external suppliers, test laboratories, and sterilization vendors to ensure timely execution of product development and launch deliverables. Required Qualifications Bachelor’s or Master’s degree in Mechanical Engineering Minimum 8 years of experience in mechanical/product validation engineering Strong experience with reusable medical devices Hands‑on experience in cleaning and sterilization validation processes Experience with test method development and qualification Knowledge of DFMEA/PFMEA and risk management processes Strong analytical, documentation, and communication skills #J-18808-Ljbffr New York Technology Partners