Engineer, Failure Analysis (Medical Devices)

Location: Irvine, California, United States; primarily office-based with some local travel

Salary: $70,000–$90,000 per year plus benefits and eligibility for up to a 10% annual bonus.

Company

Bowers & Wilkins is hiring for a role focused on failure analysis of medical devices, cables, sensors, and related electronic components.

What you will do

• Perform root cause analysis of customer-returned, newly manufactured, and prototype products.
• Troubleshoot electronic circuits at the system, module, component, and circuit-board levels using schematics and layouts.
• Investigate failures using electrical test equipment, CT X-ray scanning, optical microscopy, thermal imaging, FTIR spectroscopy, component cross-sectioning, and environmental chamber testing.
• Collaborate with Compliance, Regulatory, R&D Engineering, Operations, QA, and Manufacturing to recreate difficult or intermittent failure modes.
• Track and trend product failures, prepare reports, and document findings with photographs or samples.
• Report field failures and customer complaints, identify customer training issues, and follow up on corrective actions through closure.

Requirements

• 0–1 years of experience and a bachelor’s degree, preferably in Electrical Engineering, or equivalent education and related experience.
• Experience with quality-control testing, preferably in a medical-device environment.
• Knowledge of ISO 9000 requirements, biohazard products and procedures, and disposal compliance.
• Working knowledge of electrical testing and troubleshooting using microscopes, digital multimeters, oscilloscopes, calipers, digital cameras, and related equipment.
• Experience entering data into databases and preparing reports with Microsoft Office applications.
• Strong verbal and written communication skills, attention to detail, and a valid driver’s license for local travel.

Nice to have

• Experience with FDA regulations.
• Prior experience in repair operations and support services.

Culture & Benefits

• Medical, dental, vision, life, disability, and flexible spending benefits.
• 401(k), vacation, sick leave, holidays, and paid maternity leave.
• Additional voluntary accident, critical illness, hospital, long-term care, employee assistance, and pet insurance.
• Access to an on-site wellness clinic, fitness center, and cafe.
• Benefits are subject to eligibility requirements.