Mechanical Product Validation Engineer

Mechanical Product Validation Engineer

Rate: $35/hr.w2

Onsite - Cincinnati, Ohio

Must Have's:

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.