Senior Mechanical Validation Engineer – Medical Devices

Pentangle Tech Services | P5 Group; Cincinnati (OH); On-site; USD 90,000 - 140,000; Full time

Job summary

Pentangle Tech Services | P5 Group in Cincinnati, OH is seeking a Mechanical Product Validation Engineer responsible for developing and executing validation studies for reusable medical devices, focusing on cleaning, sterilization, and reprocessing validation.

The role involves creating test methods, performing GR&R and statistical analyses, supporting risk management, and collaborating with R&D, Quality, Regulatory, and external labs to ensure FDA/ISO compliance and timely product launches.

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent.
• 5+ years of mechanical product validation experience.
• Hands-on validation of cleaning, sterilization and reprocessing for reusable medical devices.
• Experience developing test methods, executing validation studies, and GR&R.

Responsibilities

• Develop and execute validation studies for reusable medical devices.
• Create test methods and perform GR&R, statistical analyses.
• Investigate issues via root cause analysis and recommend corrective actions.
• Support risk management activities including DFMEA, PFMEA, and Hazard Analysis.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, and external labs.

Skills

Root cause analysis

Statistical analysis

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Mechanical Engineering

Tools

GR&R analysis

Statistical software

Job description

Pentangle Tech Services | P5 Group in Cincinnati, OH is seeking a Mechanical Product Validation Engineer responsible for developing and executing validation studies for reusable medical devices, focusing on cleaning, sterilization, and reprocessing validation.

The role involves creating test methods, performing GR&R and statistical analyses, supporting risk management, and collaborating with R&D, Quality, Regulatory, and external labs to ensure FDA/ISO compliance and timely product launches.