Complaint Evaluation Engineer at Applied Medical · Rancho…

Summary: Applied Medical is a new-generation medical device company committed to innovation and quality in healthcare. The Complaint Evaluation Engineer plays a vital role in investigating medical devices and evaluating their performance, ensuring regulatory compliance and supporting continuous improvement efforts.

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

Required Qualifications:
- 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

Preferred Qualifications:
- 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

Required Skills: Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Root Cause Analysis, Spreadsheets, Word Processing, Hands-on Testing, Mechanical Evaluation, Electrical Evaluation, Medical Device Handling, Safety and Biohazard Handling Procedures

Benefits: Comprehensive benefits package., Training and mentorship opportunities., On-campus wellness activities., Education reimbursement program., 401(k) program with discretionary employer match., Generous vacation accrual and paid holiday schedule.