Medical Device Failure Analysis Engineer

Applied Medical; Rancho Santa Margarita (CA); On-site; USD 71,000 - 80,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

Training and mentorship

Wellness activities

Education reimbursement

401(k) with discretionary match

Generous vacation and holidays

Job summary

Applied Medical in California seeks a Complaint Evaluation Engineer to investigate returned medical devices, perform root cause analysis, and support post-market quality efforts. The role involves hands-on testing, documentation, and collaboration with R&D, manufacturing, and quality teams to meet FDA/ISO 13485 expectations.

Onsite position requiring a bachelor's degree in an engineering field and at least one year in a regulated setting or related lab experience.

Qualifications

• Bachelor's degree in a related engineering field.
• Minimum of 1 year in a regulated industry (medical device, pharmaceutical, lab, aerospace) or strong internship/lab experience.
• Strong problem-solving abilities, critical thinking, and root-cause mindset.
• Effective written and verbal communication skills.
• Comfortable performing hands-on testing and evaluating devices in a lab setting.
• Experience with creating engineering reports or regulatory documentation.

Responsibilities

• Perform complaint evaluations and investigations of returned medical devices using visual, mechanical, and functional assessments.
• Conduct root cause analysis by disassembling devices and recreating reported issues.
• Carry out hands-on laboratory testing with fixtures and measurement tools under simulated clinical-use conditions.
• Prepare technical reports with methods, results, conclusions, and recommendations compliant with FDA and ISO 13485.
• Collaborate with R&D, manufacturing, quality, and clinical teams to communicate findings.
• Support continuous improvement of test methods and documentation practices.
• Participate in training to strengthen technical and analytical capabilities.

Skills

Root cause analysis

Lab testing

Mechanical testing

Electrical testing

Technical documentation

Written communication

Spreadsheets

Cross-functional collaboration

Multiple investigations

Education

Bachelor's degree in Mechanical Engineering/Biomedical Engineering/Electrical Engineering

Tools

Measurement tools

Test fixtures

Job description

Applied Medical in California seeks a Complaint Evaluation Engineer to investigate returned medical devices, perform root cause analysis, and support post-market quality efforts. The role involves hands-on testing, documentation, and collaboration with R&D, manufacturing, and quality teams to meet FDA/ISO 13485 expectations.

Onsite position requiring a bachelor's degree in an engineering field and at least one year in a regulated setting or related lab experience.