Validation Engineer

Pentangle Tech Services | P5 Group; Kentucky; On-site; USD 85,000 - 125,000; Full time

Job summary

Pentangle Tech Services | P5 Group is seeking a Mechanical Product Validation Engineer in Kentucky to lead validation efforts for reusable medical devices. You will develop and execute validation studies, create test methods, perform root cause analyses, and collaborate with R&D, Quality, Regulatory, and manufacturing to ensure regulatory compliance and successful launches.

The role demands hands-on experience with cleaning, sterilization, and reprocessing validation, GR&R studies, and risk

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent.
• Minimum 5+ years of experience in mechanical product validation, preferably in the medical device industry.
• Hands-on experience with cleaning, sterilization, and reprocessing validation of reusable medical devices.
• Experience developing test methods, executing validation studies, and performing GR&R.
• Strong knowledge of root cause analysis, statistical analysis, and engineering documentation.
• Experience supporting DFMEA, PFMEA, and Hazard Analysis.

Responsibilities

• Develop soiling, cleaning, and extraction processes for reusable medical devices, including scopes, instruments, and accessories.
• 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.

Job description

We are seeking a Mechanical Product Validation Engineer with hands‑on experience in cleaning, sterilization, and reprocessing validation for reusable medical devices. The ideal candidate will support product development by developing and executing validation studies, creating test methods, performing root cause analysis, and collaborating with cross‑functional teams to ensure regulatory compliance and successful product launches.

Key Responsibilities

• Develop soiling, cleaning, and extraction processes for reusable medical devices, including scopes, instruments, and accessories.
• Plan, execute, and analyze Cleaning & Sterilization (C&S) feasibility studies, cleanability assessments, and sterilization validation activities.
• Develop and qualify test methods, perform Gage Repeatability & Reproducibility (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.

Required Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent.
• Minimum 5+ years of experience in mechanical product validation, preferably within the medical device industry.
• Hands‑on experience with cleaning, sterilization, and reprocessing validation of reusable medical devices.
• Experience developing test methods, executing validation studies, and performing GR&R.
• Strong knowledge of root cause analysis, statistical analysis, and engineering documentation.
• Experience supporting risk management activities, including DFMEA, PFMEA, and Hazard Analysis.
• Strong communication and cross‑functional collaboration skills.

Preferred Qualifications

• Experience with reusable endoscopes, surgical instruments, or similar medical devices.
• Knowledge of medical device design controls, verification, and validation processes.
• Experience working with external testing laboratories and sterilization service providers.
• Familiarity with FDA and ISO standards related to reusable medical devices.
• Strong analytical, problem‑solving, and presentation skills.