Complaint Evaluation Engineer

Applied Medical•Rancho Santa Margarita, CA

5d•Onsite

About The Position

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. Working closely with cross-functional engineering and quality teams, the complaint evaluation engineer contributes to regulatory compliance, technical documentation, and post-market surveillance activities in alignment with Food and Drug Administration standards, International Organization for Standardization (ISO) 13485 requirements, and Medical Device Reporting expectations. This position is well-suited for engineering professionals seeking experience in medical device investigation, failure analysis, and post-market quality engineering.

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
Ability 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

Nice To Haves

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.
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.
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.

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.