Senior Mechanical Validation Engineer – Med Devices

Belcan Corporation; Cincinnati (OH); On-site; USD 69,000 - 83,000; Full time

Job summary

Belcan is seeking a Mechanical Product Validation Engineer to lead cleaning, sterilization, and reprocessing validation for reusable medical devices. You will plan feasibility studies, develop test methods, perform GR&R analyses, and contribute to risk management documentation.

Collaboration with R&D, Quality, Regulatory, and external partners is essential for successful product development in a regulated setting.

Qualifications

• Bachelor's degree in Mechanical Engineering with 5+ years in the medical device industry.
• Hands-on experience in cleaning, sterilization, and reprocessing validation for reusable medical devices.
• Development and validation of cleaning/sterilization test methods and validation protocols.
• Strong knowledge of validation methodologies, including GR&R, root cause analysis, and data evaluation.
• Experience supporting risk management, design reviews, and cross-functional teams.

Responsibilities

• Develop cleaning and extraction processes for reusable scopes and accessories, considering real-use conditions.
• Plan, execute, and analyze cleaning and sterilization feasibility studies and validations.
• Create and qualify test methods, perform GR&R studies, document results with statistical analysis.
• Conduct root cause analysis for C&S issues and communicate data-driven solutions.
• Support risk management documentation (DFMEA/PFMEA) with lab input and testing support.
• Prepare documentation for design reviews and phase exits, presenting technical content.

Skills

Medical devices

Sterilization validation

GR&R studies

Statistical analysis

Technical writing

Education

B.E./B.Tech Mechanical Engineering

Job description

Belcan is seeking a Mechanical Product Validation Engineer to lead cleaning, sterilization, and reprocessing validation for reusable medical devices. You will plan feasibility studies, develop test methods, perform GR&R analyses, and contribute to risk management documentation.

Collaboration with R&D, Quality, Regulatory, and external partners is essential for successful product development in a regulated setting.