Medical Device Validation Engineer – Cleaning & Sterilization

Pentangle Tech Services | P5 Group; Kentucky; On-site; USD 85,000 - 120,000; Full time

Job summary

Pentangle Tech Services | P5 Group seeks a Mechanical Product Validation Engineer to lead validation studies for reusable medical devices, including cleaning, sterilization, and reprocessing validation. You will develop test methods and analyses, and collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure compliant product launches.

Requirements include 5+ years in mechanical product validation in the medical device sector, hands-on cleaning/sterilization validation, GR&R, and

Qualifications

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

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, with lab input.
• 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

Cleanability validation

GR&R studies

Root cause analysis

Risk management

Statistical analysis

Validation protocols

Cross-functional collaboration

Design reviews

Phase exit reviews

Engineering documentation

Education

Bachelor's degree in Mechanical Engineering

Job description

Pentangle Tech Services | P5 Group seeks a Mechanical Product Validation Engineer to lead validation studies for reusable medical devices, including cleaning, sterilization, and reprocessing validation. You will develop test methods and analyses, and collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure compliant product launches.

Requirements include 5+ years in mechanical product validation in the medical device sector, hands-on cleaning/sterilization validation, GR&R, and