Complaint Evaluation Engineer

About the role

The Complaint Evaluation Engineer plays a critical role in Applied Medical’s post-market quality and patient safety efforts by investigating returned medical devices and evaluating real-world product performance. This hands-on, laboratory-based engineering role focuses on device teardown, functional and mechanical testing, and recreation of reported product issues to determine root cause and support continuous improvement.

Responsibilities

• Perform complaint evaluations and investigations by conducting visual, mechanical, and functional assessments of returned medical devices to evaluate real-world product performance.
• Execute root cause analysis activities by disassembling devices, recreating reported issues, and applying structured problem-solving methodologies to identify underlying causes.
• Conduct hands-on laboratory testing and troubleshooting using test fixtures, measurement tools, and simulated clinical-use conditions to validate investigative findings.
• Prepare technical documentation and reports that clearly summarize test methods, results, conclusions, and recommendations in accordance with FDA, ISO 13485, and Medical Device Reporting requirements.
• Collaborate cross-functionally with research and development, manufacturing, quality, and clinical development teams to communicate findings and support post-market regulatory activities.
• Support continuous improvement initiatives by contributing to enhancements in test methods, investigative processes, and documentation practices.
• Participate in training and professional development to apply feedback constructively and strengthen technical and analytical capabilities.

Requirements

• Work onsite in a highly collaborative engineering and laboratory environment
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related field
• Minimum of one year of experience in a regulated industry, such as medical device, pharmaceutical, laboratory, aerospace, or strong internship and lab experience
• Demonstrate strong problem-solving abilities, critical thinking, and a root-cause-focused mindset
• Able to take and apply feedback constructively
• Effective written and verbal communication skills
• Proficient with spreadsheets, word processing, and technical documentation tools
• Strong organizational skills and the ability to manage multiple investigations simultaneously
• Comfortable performing hands-on testing, troubleshooting, and mechanical/electrical evaluation of devices
• Comfortable handling, inspecting, and testing returned medical devices that have been used in clinical and surgical environments, in accordance with safety and biohazard handling procedures

Preferred

• Experience with failure analysis, complaint investigations, or reliability testing in a regulated environment
• Familiarity with post-market regulatory systems, including Medical Device Reporting, corrective and preventive action processes, and quality management system requirements
• Understanding of laboratory testing protocols and test equipment used in mechanical or electrical evaluation
• Experience working in an FDA-regulated or ISO 13485-certified organization
• Technical writing experience, including preparation of engineering reports or regulatory documentation
• Strong analytical capability with an ability to understand integrated mechanical and electrical systems

Benefits

• Competitive compensation range: $71,000 - $80,000 / year (California)
• Comprehensive benefits package
• Training and mentorship opportunities
• On-campus wellness activities
• Educational reimbursement program
• 401(k) program with discretionary employer match
• Generous vacation accrual and paid holiday schedule

Schedule

Full-time, Monday through Friday, 8:00 AM - 4:30 PM

Pay

$71,000 - $80,000 / year (California)