Mechanical Product Validation Engineer

Pentangle Tech Services | P5 Group; Cincinnati (OH); In loco; USD 110.000 - 140.000; Tempo pieno

Descrizione del lavoro

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),

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Mechanical validation

Root cause analysis

Statistical analysis

Cross-functional collaboration

DFMEA/PFMEA

Hazard Analysis

Validation planning

GR&R studies

Test method development

Formazione

Bachelor's degree in Mechanical Engineering

Descrizione del lavoro

Job Summary

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.

Project Duration

24 Months

Location

Cincinnati, Ohio

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.