Mechanical Product Validation Engineer

TechDigital Group; Cincinnati (OH); On-site; USD 80,000 - 100,000; Full time

Job summary

TechDigital Group is seeking a Mechanical Product Validation Engineer in Cincinnati, Ohio. The candidate will have hands-on expertise in cleaning and sterilization validation for reusable medical devices. Responsibilities include developing and executing feasibility studies, conducting root cause analysis, and supporting risk management documentation. The ideal candidate should be skilled in test method development and have the ability to communicate technical content effectively to cross-functional teams. This role is vital in ensuring product quality and compliance with industry standards.

Qualifications

• Hands-on expertise in cleaning, sterilization, and reprocessing validation for reusable medical devices.
• Experienced in developing test methods and executing feasibility and validation studies.
• Strong knowledge in statistical analysis and technical documentation.

Responsibilities

• Develop cleaning and sterilization processes for reusable medical devices.
• Plan and execute feasibility studies and cleanability assessments.
• Document results in engineering studies and validation documentation.
• Conduct root cause analysis for cleaning and sterilization issues.
• Support risk management documentation development.
• Prepare documentation for design reviews.

Skills

Cleaning & Sterilization Validation

Test Method Development

DFMEA

Product Quality

Job description

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.