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Applied Medical · 17 hours ago

Complaint Evaluation Engineer

Rancho Santa Margarita, CA

Full-time

Onsite

New Grad, Entry Level

$71K/yr - $80K/yr

Applied Medical is a new-generation medical device company with a commitment to innovation and excellence in the healthcare field. The Complaint Evaluation Engineer plays a critical role in investigating returned medical devices and evaluating their performance to ensure quality and patient safety, collaborating closely with engineering and quality teams to support regulatory compliance and continuous improvement efforts.

BiotechnologyHealth CareMedicalMedical Device

H1B Sponsor Likely

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

Qualification

Failure analysisRoot cause analysisTechnical documentationLaboratory testingRegulatory complianceAnalytical capabilityCollaborationProblem-solvingTechnical writing

Required

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

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

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

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.

Company

Applied Medical

Glassdoor3.2

As a new generation medical device company, Applied Medical is focused on meeting three fundamental healthcare needs: enhanced clinical outcomes, cost containment and unrestricted choice.

Founded in 1987

Rancho Santa Margarita, California, USA

5001-10000 employees

http://www.appliedmedical.com

H1B Sponsorship

Applied Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (37)

2024 (32)

2023 (23)

2022 (34)

2021 (18)

2020 (12)