Medical Device Failure Analysis Engineer

Applied Medical; Rancho Santa Margarita (CA); Vor Ort; USD 71.000 - 80.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Comprehensive benefits

Training and mentorship

Wellness activities

Education reimbursement

401(k) with discretionary match

Generous vacation and holidays

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Root cause analysis

Lab testing

Mechanical testing

Electrical testing

Technical documentation

Written communication

Spreadsheets

Cross-functional collaboration

Multiple investigations

Ausbildung

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

Tools

Measurement tools

Test fixtures

Jobbeschreibung

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.