Senior Mechanical Validation Engineer - Medical Devices

Pentangle Tech Services | P5 Group; Cincinnati (OH); On-site; USD 110,000 - 140,000; Full time

Job summary

Pentangle Tech Services | P5 Group in Cincinnati, OH seeks a Mechanical Product Validation Engineer with hands-on experience in cleaning, sterilization, and reprocessing validation for reusable medical devices. You will develop validation studies, create test methods, perform root cause analysis, and collaborate with cross-functional teams to ensure regulatory compliance and successful product launches.

The role emphasizes GR&R studies, risk management support (DFMEA/PFMEA and Hazard Analysis),

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent.
• 5+ years in mechanical product validation, preferably medical devices.
• Hands-on validation of cleaning, sterilization, and reprocessing of reusable devices.
• Experience developing test methods and executing validation studies.
• Strong knowledge of root cause analysis and statistical methods.
• Experience with DFMEA, PFMEA and Hazard Analysis.
• Excellent cross-functional communication and collaboration.

Responsibilities

• Develop soiling, cleaning, and extraction processes for reusable medical devices.
• Plan, execute, and analyze cleaning & sterilization feasibility studies and sterilization validation.
• Develop and qualify test methods, perform GR&R studies, and prepare validation reports.
• Investigate cleaning and sterilization issues using root cause analysis and recommend corrective actions.
• Support risk management activities (DFMEA, PFMEA, Hazard Analysis) with lab input.
• Participate in Design Reviews and Phase Exit Reviews; present validation results.
• Collaborate with R&D, Quality, Regulatory, Manufacturing and external labs.
• Ensure validation activities comply with quality standards and timelines.

Skills

Mechanical validation

Root cause analysis

Statistical analysis

Cross-functional collaboration

DFMEA/PFMEA

Hazard Analysis

Validation planning

GR&R studies

Test method development

Education

Bachelor's degree in Mechanical Engineering

Job description

Pentangle Tech Services | P5 Group in Cincinnati, OH seeks a Mechanical Product Validation Engineer with hands-on experience in cleaning, sterilization, and reprocessing validation for reusable medical devices. You will develop validation studies, create test methods, perform root cause analysis, and collaborate with cross-functional teams to ensure regulatory compliance and successful product launches.

The role emphasizes GR&R studies, risk management support (DFMEA/PFMEA and Hazard Analysis),