Mechanical Validation Engineer - Cleaning & Sterilization

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

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.