Senior Reliability Engineer, Medical Devices & NPI

Fujifilm; Bothell (WA); On-site; USD 104,000 - 115,000; Full time

Benefits offered by this job

Medical, Dental & Vision

Life & Disability

401k with company match

PTO and holidays

Job summary

FUJIFILM Sonosite in Bothell, WA is seeking a Reliability Engineer to support R&D Systems Engineering of point-of-care ultrasound devices. You will champion Design for Reliability early in development and lead reliability analyses, HALT testing, and risk assessments across hardware and software.

As an individual contributor, you will collaborate with cross-functional teams—Product Management, Manufacturing, Quality, and Service—to ensure product integrity throughout lifecycle and drive

Qualifications

• BS in engineering, statistics, or data analysis; MS preferred.
• 5+ years in a medical or regulated industry with DfR experience.
• Expertise in reliability software tools (Reliasoft, Weibull++, Minitab).
• Experience with safety risk management (FMEA, hazard analyses).
• Ability to lead reliability programs across hardware and software.

Responsibilities

• Lead reliability analyses, HALT tests, and reliability demonstration tests.
• Develop test plans and preliminary reliability assessments.
• Collaborate with cross-functional teams to meet reliability goals.
• Create and release reliability documentation and reports.

Skills

Strong communication

Statistics and data analysis

Customer focus

Leadership

Mentor/teach

Design for Reliability

Team collaboration

Ability to lift 25 pounds

Education

BS in relevant engineering, statistics, or data analysis

MS degree preferred

Tools

Reliasoft

Weibull++

Minitab

ISO 14971

IEC 60601-1

IEC 60601-2-37

Job description

FUJIFILM Sonosite in Bothell, WA is seeking a Reliability Engineer to support R&D Systems Engineering of point-of-care ultrasound devices. You will champion Design for Reliability early in development and lead reliability analyses, HALT testing, and risk assessments across hardware and software.

As an individual contributor, you will collaborate with cross-functional teams—Product Management, Manufacturing, Quality, and Service—to ensure product integrity throughout lifecycle and drive