Medical Device Failure Analysis Engineer

Masimo; Irvine (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life/AD&D

Disability Insurance

401(k)

Vacation

Sick

Holiday

Paid Maternity Leave

Flexible Spending Accounts

Voluntary Accident

Critical Illness

Hospital

Long-Term Care

Employee Assistance Program

Pet Insurance

On-site wellness clinic

Fitness center

Cafe

Job summary

Masimo is seeking a Failure Analysis Engineer to perform root cause analysis on customer returns, newborn manufactured and prototype products. This role involves working with Compliance, Regulatory, R&D Engineering, Operations and QA to understand failures and identify product improvements.

The successful candidate will analyze electronics at system/module/component levels, use a range of testing instruments, and collaborate across functions to reproduce and document failures and drive

Qualifications

• ISO-9000 requirements knowledge
• Electrical testing knowledge and testing equipment such as microscopes, digital cameras, calipers, digital multimeters, oscilloscopes
• Data entry into database programs and ability to manipulate data for reporting using MS Office
• Good communication skills both verbal and written, and detail-oriented

Responsibilities

• Perform root cause analysis using a wide range of techniques and engineering principles on Masimo products
• Analyze and troubleshoot electronic circuits at system, module, and component levels
• Investigate products using analytical instruments and testing equipment
• Collaborate with cross-functional teams to reproduce intermittent/hard-to-replicate failures
• Track and trend product failures and report new/trending failure modes
• Collaborate with QA, R&D Engineering and Manufacturing to report status and recommendations
• Document significant findings with photos or samples for QA/R&D
• Identify root causes of customer returned product failures
• Identify potential customer training issues and propose solutions
• Report field failures and customer complaints per Masimo Quality System
• Follow up to ensure closure of product and training issues
• Monitor Customer/Technical support processes and implement improvements
• Maintain regular attendance and perform other duties as assigned

Skills

Good communication

Root cause analysis

Education

Bachelor’s degree in Electrical Engineering

Tools

Microscopes

Digital cameras

Calipers

Digital multimeters

Oscilloscopes

MS Office

Job description

Masimo is seeking a Failure Analysis Engineer to perform root cause analysis on customer returns, newborn manufactured and prototype products. This role involves working with Compliance, Regulatory, R&D Engineering, Operations and QA to understand failures and identify product improvements.

The successful candidate will analyze electronics at system/module/component levels, use a range of testing instruments, and collaborate across functions to reproduce and document failures and drive