Mechanical Product validation Engineer

Job Title: Mechanical Product Validation Engineer

Location: Cincinnati, OH (Onsite)

Tax Term: W2

Job Type: Contract

Duration: Long-Term

Job Description:

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.

Roles & 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.

Required Skills:

• Cleaning & Sterilization Validation
• Cleaning & Sterilization (C&S) Feasibility Studies
• Reprocessing Validation
• Test Method Development
• Cleanability Assessment
• Sterilization Validation
• Gage Repeatability & Reproducibility (GR&R)
• Root Cause Analysis
• Product Quality
• DFMEA
• PFMEA
• Hazard Analysis
• Risk Management
• Medical Devices
• Reusable Scopes
• Instruments & Accessories (I&A)
• Engineering Studies
• Validation Documentation
• Statistical Analysis
• Design Reviews
• Phase Exit Reviews
• Cross-Functional Collaboration

Qualifications:

• B.E. in Mechanical Engineering or equivalent.
• 5 10 years of relevant experience.
• Hands-on experience with cleaning, sterilization, and reprocessing validation for reusable medical devices.
• Experience developing and qualifying test methods and conducting GR&R studies.
• Strong experience with root cause analysis and product quality.
• Experience supporting DFMEA, PFMEA, hazard analysis, and other risk management activities.
• Experience collaborating with R&D, quality, engineering, suppliers, test laboratories, and sterilization vendors.
• Strong technical documentation, analytical, and communication skills.