Mechanical Product Engineer

Job Summary

We are seeking a Product Quality Engineer to investigate Out-of-Box Failures (OOBFs), installation issues, and field-returned medical devices. This role is responsible for performing detailed electrical and mechanical failure investigations, identifying root causes, supporting CAPA activities, and collaborating with cross-functional teams to improve product quality, reliability, and customer satisfaction.

Key Responsibilities

• Investigate Out-of-Box Failures (OOBFs), installation issues, and customer-reported product failures.
• Perform hands-on electrical and mechanical troubleshooting of returned medical devices.
• Replicate field failures in a Quality Engineering laboratory environment.
• Conduct Root Cause Analysis using structured methodologies such as 5 Whys, Fishbone Diagrams, and Fault Tree Analysis.
• Analyze electrical schematics, wiring diagrams, mechanical drawings, test data, diagnostic logs, and system performance data.
• Determine whether failures are related to product design, electrical components, mechanical assemblies, manufacturing processes, supplier quality, or installation practices.
• Prepare comprehensive technical investigation reports with clear documentation of findings and recommendations.
• Collaborate with R&D, Manufacturing, Service, Supplier Quality, and Quality Assurance teams to resolve complex product issues.
• Lead or support CAPA investigations and implement corrective and preventive actions to eliminate recurring failures.
• Participate in product remediation and continuous improvement initiatives to enhance product reliability and reduce field failures.
• Ensure investigations are completed accurately, thoroughly, and within established timelines.

Preferred Qualifications

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 3–8 years of experience in Quality Engineering, Product Quality, Failure Analysis, Reliability Engineering, or Medical Device Engineering.
• Experience troubleshooting electromechanical systems.
• Strong knowledge of Root Cause Analysis methodologies and CAPA processes.
• Ability to interpret electrical schematics, mechanical drawings, and engineering documentation.
• Experience with field failure investigations, returned product analysis, or complaint investigations.
• Excellent analytical, troubleshooting, and technical communication skills.