Failure Analysis Engineer

We are seeking a hands‑on Failure Analysis Engineer to support quality engineering and product investigation activities for a leading medical device manufacturer. This role focuses on investigating Out‑of‑Box Failures (OOBFs) and installation‑related product failures by performing detailed electrical and mechanical analysis to determine root cause and drive product improvements. The ideal candidate will have experience troubleshooting complex medical devices, conducting root cause investigations, and collaborating with cross‑functional engineering teams in a regulated environment. Key Responsibilities Investigate Out‑of‑Box Failures (OOBFs) and installation‑related product failures reported from the field Perform hands‑on electrical and mechanical troubleshooting on returned medical device systems Replicate, analyze, and diagnose product failure modes in a Quality Engineering laboratory Conduct Root Cause Analysis (RCA) using methodologies such as 5 Whys, Fishbone, and Fault Tree Analysis Analyze electrical schematics, wiring diagrams, mechanical drawings, test data, and system logs Determine whether failures are related to electrical components, mechanical design, manufacturing defects, supplier quality, or installation issues Document investigation findings and communicate technical conclusions Collaborate with R&D, Manufacturing, Service, Supplier Quality, and Quality Engineering teams Support CAPA investigations and corrective actions to prevent recurrence Contribute to remediation activities by completing timely, high‑quality investigations Required Qualifications Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related discipline 5+ years of experience in Failure Analysis, Quality Engineering, Product Investigation, or Sustaining Engineering Medical Device industry experience preferred Strong hands‑on electrical and mechanical troubleshooting skills Experience performing Root Cause Analysis (RCA) Ability to interpret electrical schematics, wiring diagrams, and mechanical drawings Experience supporting CAPA investigations and quality improvement initiatives Strong analytical, documentation, and communication skills Preferred Qualifications Experience investigating Out‑of‑Box Failures (OOBFs) Knowledge of FDA Quality System Regulations and ISO 13485 Experience supporting complaint investigations and product remediation projects Compensation is based on experience. This is a contract position and does not include employer‑provided benefits. Equal Opportunity Employer We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Background checks may be conducted in accordance with applicable laws. Work Authorization Applicants must be authorized to work in the United States. #J-18808-Ljbffr Novozen Healthcare LLC