Mech Product Validation Engineer - Cleaning & Sterilization

Pentangle Tech Services | P5 Group; Kentucky; On-site; USD 85,000 - 110,000; Full time

Job summary

Pentangle Tech Services | P5 Group seeks a Mechanical Product Validation Engineer to drive validation of cleaning, sterilization, and reprocessing for reusable medical devices. You will develop test methods, perform GR&R analyses, and collaborate with cross-functional teams to ensure regulatory compliance and successful product launches.

The role requires 5+ years in mechanical validation within medical devices, with hands-on experience in C&S processes, RFMEA, and risk management.

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent.
• 5+ years of mechanical product validation experience in medical devices.
• Hands-on cleaning, sterilization, and reprocessing validation experience.
• Experience developing test methods and executing validation studies.
• Proficiency in root cause analysis and statistical methods.
• Knowledge of DFMEA, PFMEA, Hazard Analysis and risk management.

Responsibilities

• Develop cleaning, soiling, and extraction processes for reusable medical devices.
• Plan, execute, and analyze Cleaning & Sterilization (C&S) feasibility studies, cleanability assessments, and sterilization validation activities.
• Develop and qualify test methods, perform GR&R studies, and prepare validation protocols, reports, and statistical analyses.
• Investigate cleaning and sterilization process issues using root cause analysis and recommend corrective actions.
• Support risk management activities, including DFMEA, PFMEA, and Hazard Analysis, by providing technical input and laboratory expertise.
• Participate in Design Reviews and Phase Exit Reviews, preparing technical documentation and presenting validation results.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, and external testing laboratories to support product development and commercialization.
• Ensure validation activities comply with quality standards, regulatory requirements, and project timelines.

Skills

GR&R

Root cause analysis

Risk management

Cross-functional collaboration

Statistical analysis

Validation studies

Education

Bachelor's degree in Mechanical Engineering

Job description

Pentangle Tech Services | P5 Group seeks a Mechanical Product Validation Engineer to drive validation of cleaning, sterilization, and reprocessing for reusable medical devices. You will develop test methods, perform GR&R analyses, and collaborate with cross-functional teams to ensure regulatory compliance and successful product launches.

The role requires 5+ years in mechanical validation within medical devices, with hands-on experience in C&S processes, RFMEA, and risk management.