Mechanical Validation Engineer – Medical Devices (C&S)

Belcan; Cincinnati (OH); On-site; USD 104,000 - 125,000; Full time

Job summary

Belcan seeks a Mechanical Product Validation Engineer in Cincinnati to lead cleaning, sterilization, and reprocessing validation for reusable medical devices. You will plan feasibility studies, develop test methods, and perform GR&R analyses to ensure safety and compliance.

Collaboration with R&D, Quality, and Regulatory is essential. The role requires 5–10 years of industry experience, strong statistical analysis, and hands-on lab work.

Qualifications

• Bachelor's in Mechanical Engineering or equivalent required.
• Hands-on expertise in cleaning, sterilization, and reprocessing validation for reusable medical devices.
• Experience developing and validating cleaning/sterilization test methods and validation protocols.
• Knowledge of validation methodologies, including GR&R, RCA, and statistical data evaluation.
• Experience supporting risk management activities and cross-functional teams in product development lifecycle.

Responsibilities

• Develop soiling, cleaning and extraction processes for reusable scopes and instruments.
• Plan and execute Cleaning and Sterilization feasibility studies and validations.
• Create and qualify test methods; perform GR&R studies and document results.
• Conduct root cause analysis for C&S issues and provide data-driven recommendations.
• Support risk management documentation (DFMEA/PFMEA, hazard analyses).
• Support Design Reviews and Phase Exit Reviews with documentation and presentations.
• Coordinate with internal teams and external labs/vendors to meet timelines.

Skills

Cleaning validation

Sterilization

GR&R studies

Root cause analysis

Statistical analysis

Cross-functional collaboration

Education

Bachelor's in Mechanical Engineering

Job description

Belcan seeks a Mechanical Product Validation Engineer in Cincinnati to lead cleaning, sterilization, and reprocessing validation for reusable medical devices. You will plan feasibility studies, develop test methods, and perform GR&R analyses to ensure safety and compliance.

Collaboration with R&D, Quality, and Regulatory is essential. The role requires 5–10 years of industry experience, strong statistical analysis, and hands-on lab work.