Mechanical Engineer

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

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.